Sr No API NAME IMPURITY 1 Abacavir Sulfate a) N6 -cyclopropyl-9H-purine-2, 6-diamine Abacavir Sulfate b) (1S, 4R)-4-[2-Amino-6-(cyclopopylamino)-9H-purin-9-yl]-1-(2, 5-diamino-6-chloro-4pyrimidinyloxy) methyl-2-cyclopentene. c) (1S,4R)-4-(2- Amino-6-chloro-9H-purin-9-yl)-2-cyclopentene-1-methanol hydrochloride 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Abacavir Sulfate Abacavir Sulfate Abiraterone Acetate Abrisentan Abrisentan Abrisentan Abrisentan Abrisentan Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Aceclofenac Acetazolamide Acetazolamide Acetazolamide Acetazolamide Acetazolamide ACETAZOLAMIDE ACETAZOLAMIDE ACETAZOLAMIDE ACETAZOLAMIDE d) (1S, 4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl] cyclopentatne-1- methanol sulfate. (ABSRCO2 ) (3β)-17-(3-Pyridinyl) androsta-5, 16-dien-3-0l. a)2-[(2,2 Diphenylvinyl)oxy]-4,6-dimethylpyrimidine. b)(R)-2-(4,6-Dimethyl-2-pyrimidinyloxy)-3-methoxy-3,3diphenyl propanoic acid. c)2S-Hydroxy-3-methoxy-3,3-diphenyl propanoic acid. d)2S-[(4,6-Dimethylpyrimidin-2-yl]-3-methoxy-3,3-diphenyl propanoic acid methyl ester d)2S-[(4,6-Dimethylpyrimidin-2-yl]-3-methoxy-3,3-diphenyl propanoic acid methyl ester Aceclofenac EP Imp F Aceclofenac EP Imp E Aceclofenac EP Imp G Aceclofenac EP Imp G Aceclofenac EP Imp H Aceclofenac Impurity A Aceclofenac Impurity B Aceclofenac Impurity C Aceclofenac Impurity D Aceclofenac Impurity G Aceclofenac Impurity I Aceclofenac Impurity E a) 2- (Acetyl. Amino)-1,3,4-thiadiazole b) 2- (acetyl. Amino)-1,3,4-thiadiazole-5-thiol c) 2-(acetyl amino)-1,3,4-thiadiazole-5 sulfonamide d) 4-Amino -2-(trifluoromethyl) benzonitrile. e) 4-Amino -3-(trifluoromethyl) benzonitrile. Impurity A Impurity B Impurity C Impurity D "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 ACETAZOLAMIDE ACETAZOLAMIDE ACETAZOLAMIDE ACETAZOLAMIDE Acetyl salicylic anhydride Acyclovir Adefovir Dipivoxil Adefovir Dipivoxil Alfuzosin Hydrochloride Alfuzosin Hydrochloride Alfuzosin Hydrochloride Alfuzosin Hydrochloride Almotriptan Almotriptan Alvimopan Monohydrate Alvimopan Monohydrate Alvimopan Monohydrate Ambroxol Ambroxol Ambroxol Ambroxol Ambroxol Amiodarone Amiodarone Amlodipine Amlodipine Amlodipine Amlodipine Amlodipine Besylate Impurity E Impurity F Impurity G Acetazolamide CAS No 59-66-5 Acetyl salicylic anhydride Acyclovir Related Compound A a) 9-[[[2-hydroxy phospninyl] methoxy] ethyl] adinine. b) (Pivaloyloxy) methyl. Hydrogen (2-(6-amino-9H-purin-9-yl)ethoxy) methyl phosphonate a) N-[3-[(4-Amino-6,7-dimethoxyquinozolin-2-yl)(methyl)amino]propyl] formamide b) N-[3-[(4-Amino-6,7-dimethoxyquinozolin-2-yl](methyl)amino]propyl]furan-2-carboxamide hydrochloride. c) 2-Chloro-6,7-dimethoxyquinazolin-4-amine d) N-(4-Amino-6,7-dimethoxyquinazolin-2yl)-N-methylpropane-1,3-diamine hydrochloride salt. Almotreptan Maleate B Almotreptan Maleate C a) [[2(R) – [[4-(R)-(3-Hydroxyphenyl)-3(R),4-dimethyl-1-piperidinyl]methyl]-1-oxo-3phenylpropyl]amino]acetic acid. b)1-hydroxy benzo triazole c) (2S, 3R, 4R)-4-(3-Hydroxyphenyl)-3, 4-dimethyl-alpha-(phenylmethyl)-1-piperidine propanoic acid monohydrate. Ambroxol Impurity-A Ambroxol Impurity-B Ambroxol Impurity-C Ambroxol impurity D Ambroxol Impurity-E Amiodarone Impurity D Amiodarone Impurity B Amlodipine EP Imp A Amlodipine EP Imp B Amlodipine EP Imp D Amlodipine EP Imp H a)3-Ethyl5-methyl(4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2(methylcabanoyl)benzoyl]amino]ethyl]methyl]-1,4-dihydropryridine-3,5-dicarboxylate.(EP-B) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Amlodipine Besylate 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 Amlodipine Besylate Amlodipine Besylate c)3-Ethyl5-methyl2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5dicarboxylate .(EP-D) Amlodipine Besylate Amlodipine Amlodipine Amoxicillin Amtolmetin Guacil Amtolmetin Guacil Amtolmetin Guacil Amlodipine Methyl Besylate Amlodipine Ethyl Besylate Amoxicillin diketopiperizine a)1-Methyl-5-(4-methylbezoyl)-1H-pyrrole-2-acetic acid. b)N-[[1-Methyl-5-(4-methylbenzoyl)-1H-pyrrol-2-yl]acetyl]glycine. ANAMICA Anastrozole Anastrozole Anastrozole ANAMICA(O-FLUORO NITROBENZENE) a)2,2’-[5-(4H-1,2,4-Triazol-4-ylmethyl)-1,3-phenylene]di(2-methylpropiononitrile). b) 2,2’-[5-(Di 1H-1,2,4-triazol-1-ylmethyl)-1,3-phenylene]di(2-methylpropiononitrile) Anastrozole Anastrozole Antipyrine Aprepitant 78 c) 2,2’-[5-[2,5-Dioxotetrahydro-1H-1-pyrroly)methyl]-1,3-phenylene]di(2-methylpropiononitrile) d)2,2’-(5-Methyl-1,3-phenylene)di(2-methylpropiononitrile). e) 2,2’-(5-Bromomethyl-1,3-phenylene)di(2-methylprpiononitrile). 4-Methylamino Antipyrine a) 5-[2(S)-[1(R)-[3,5-Bis(trifluoromethyl)phenyl] ethoxy]]-3(S)-(4-flurophenyl)morpholin-4-ylmethyl]-3,4-dihydro-2H-1,2,4-triazole-3-one. Aprepitant b) Methyl2-[2-((2R,3S)-2-((IR)-1-(3,5-bis(trifluoromethyl)phenyl)ehoxy)-3-(4-fluorophenyl)-4morpholinyl)-1-iminoethyl]hydrazine carboxlate. Aprepitant c) (IR)-1-[3,5-Bis(trifluoromethyl)phenyl](2R,3S)-3-(4-Flurophenyl) morpholinyl ether,p-toluene sulfonic acid salt, Aripiprazole 4, 4\'-dimer a)7-(4-Bromobutoxy)-1,2,3,4-tetrahydroquinoline-2-one. b)1-(2,3-Dichlorophenyl)piperazine hydrochloride. c)1-[4-[4-(2,3-Dichlorohenyl)piperazin-1-yl]butyl]-7-hydroxy-3,4-dihydrocarbostyril. d)6-[4-[(2-oxo-1,2,3,4-terahydro-7-quinolinyl)oxy]butoxy]-1,2,3,4-tetrahydro-2-quinolinone. e)7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl] butoxy]-3,4-dihydro-2(IH)-quinolinone.-N-oxide Aspirin IMPURITY A Aspirin IMPURITY C Aspirin IMPURITY B 79 80 81 82 83 84 85 86 87 88 89 b)3-Ethyl5-methyl(4RS)-4-(2-Chlorophenyl)—[[2-(1,3-dioxo-1,3-dihydro-2H-isonido-2yl)ethoxy]methyl]-6-methyl-1,4dihydropyridine-3,5-dicarboxylate. (EP-A) Aripiprazole Aripiprazole Aripiprazole Aripiprazole Aripiprazole Aripiprazole Aspirin Aspirin Aspirin "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 90 91 92 93 94 95 Aspirin Aspirin Aspirin Aspirin Aspirin Aspirin Atazanavir Sulfate Aspirin IMPURITY E 4-Hydroxybenzoic acid 4-hydroxyisophthalic acid Acetylsalicylsalicylic acid Salicylsalicylic acid Acetylsalicylic anhydride Atazanavir Sulfate b) (3S,8R,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid di mehyl ester. Atazanavir Sulfate c) (3R,8R,9S,12R)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid di mehyl ester. Pyridinyl benzoic acid Pyridinyl benzaldehyde........... Atenolol Imp C Atenolol Imp D Atenolol Imp G Atenolol Imp H Atenolol Imp A Atenolol Imp B Atenolol Imp E Atenolol Imp F a) S(+) N-Methyl-3-(2-methylphenoxy)-3-phenylpropylamine hydrochloride. b) Phenyl-N-methyl-N-[3-(-O-tolyloxy)-3-phenylpropyl]carbamate. c) L(+)- Mandelic acid. Atorvastatin-D5 O-OH Atorvastatin-D5 p-OH Atorvastatin-D5 o-OH Atorvastatin p-OH Atorvastatin 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 Atazanavir sulfate Atazanavir sulfate Atenolol Atenolol Atenolol Atenolol Atenolol Atenolol Atenolol Atenolol Atomoxetine hydrochloride Atomoxetine hydrochloride Atomoxetine hydrochloride Atorvastatin Atorvastatin Atorvastatin Atorvastatin Atorvastatin Atorvastatin Calcium ATORVASTATIN ATORVASTATIN ATORVASTATIN a) (3R,8S,9S,12R)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid di mehyl ester. a) Tert –butyl2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylacarbamoyl)1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate. ((USPRCI) ATORVASTATIN IMPURITY-A ATORVASTATIN IMPURITY ATORVASTATIN IMPURITY-H "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 ATORVASTATIN ATORVASTATIN ATORVASTATIN ATORVASTATIN ATORVASTATIN ATORVASTATIN ATORVASTATIN Atovaquone Atovaquone Atovaquone Azacitidine Azacitidine Azacitidine Azelastine Azelastine Azelastine Azelastine Azelastine Azilsartan Kamedoxomil Azilsartan Kamedoxomil Azilsartan Kamedoxomil Azilsartan Kamedoxomil Azilsartan Azilsartan Azilsartan Azilsartan Azilsartan Azilsartan Azilsartan Azilsartan Azithromycin Azithromycin Azithromycin Azithromycin Azithromycin ATORVASTATIN IMPURITY-E Atorvastatin D5 Ca Salt O-Hydroxy Atorvastatin Ca Salt P- Hydroxy Atorvastatin Ca Salt O-Hydroxy Atorvastatin D5 Ca Salt P- Hydroxy Atorvastatin D5 Ca Salt Epoxide Impurity D 2-[Cis-4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalene dione. a) 4-(4-Chlorophenyl)-cyclohexane carboxylic acid. b) 2-Chloro-3-[4-(4-chlorophenyl)cyclohexyl]-[1,4]naphthaquinone. a)4-Amino-1,3,5-triazin-2(1H)-one. b)1-(2, 3, 5-Tri-o-acetyl-β-D-ribofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one, N-(formylamidino)-N1-â -D-ribofuranosylurea Azelastine impurity-A Azelastine impurity-C Azelastine Imp B Azelastine Imp D Azelastine Imp E a) 2-Ethoxy-1-((2’-(5-oxo-4,5-dihydro1,2,4-oxadizol-3-yl)methyl)-1Hbenzo[d]imidazole-7-carboxylic acid. b) Methyl-2-ethoxy-1-((2-‘-(5-oxo-4,5-dihydro-1,2,4,-oxadizol-3yl)biphenyl-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylic acid.. Azilsartan Impurity 1 Azilsartan Impurity 2 Azilsartan Impurity 3 Azilsartan Impurity 4 Azilsartan Impurity 5 Azilsartan Impurity 6 Azilsartan Impurity 7 Azilsartan Impurity 8 Azithromycin Impurity E Azithromycin Impurity J Azithromycin Impurity L Azithromycin Impurity N Azithromycin Impurity A "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 Azithromycin Azithromycin Azithromycin Azithromycin Azithromycin Azithromycin Impurity I Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Azithromycine Bendamustine Hydrochloride Bendamustine Hydrochloride Bendamustine Hydrochloride Bendamustine Hydrochloride Bendamustine Hydrochloride Bendamustine Bendamustine Azithromycin Impurity B Azithromycin Impurity F Azithromycin Impurity G Azithromycin Impurity M Azithromycin Impurity H Azithromycin Impurity I a) Azithromycine Impurity A b) Azithromycine Impurity B c) Azithromycine Impurity E d) Azithromycine Impurity F e) Azithromycine Impurity G f Azithromycine Impurity H g) Azithromycine Impurity I h) Azithromycine Impurity J i) Azithromycine Impurity L j) Azithromycine Impurity M k) Azithromycine Impurity N l) Azithromycine Impurity O A) 1H-benzimidazole-1-methyl-5-N,N-di(2-chloro ethyl)-2-butanoic acid ethyl ester. a) 4-(7,8-dihydro-6-(2-Chloroethylamino)-3-methyl-1,4-thiazino[3,2g]benzimidazoly(2)butyric acid. b) 4-(6-bis(2-hydroxy)amino-3-methylbenzimidazoyl(2)buttyric acid.() c) 4-(6-((2-Chloroethyl)(2-hydroxyethyl)amino)-methylbenzimidazoyl-(2)butyric acid HP-1 Impurity 4-{5-[(2-Chloro-ethyl)-(2-hydroxy-ethyl)-amino]-1-methyl-1H-benzoimidazol -2-yl}-butyric acid 181 182 183 184 185 186 187 188 Bendamustine Bendamustine Bendamustine Bendamustine Bendamustine Bendamustine Bendamustine BENDROFLUMETHIAZIDE HP-2 Impurity 4-{5-[Bis-(2-hydroxy-ethyl)-amino]-1-methyl-1H-benzoimidazol-2-yl}-butyric acid. HP-1 Ester 4-{5-[(2-Chloro-ethyl)-(2-hydroxy-ethyl)-amino]-1-methyl-1H-benzoimidazol-2-yl}butyric acid isopropyl ester Methyl ester 4-{5-[Bis-(2-chloro-ethyl)-amino]-1-methyl-1H-benzoimidazol-2-yl}-butyric acid methyl ester BEN-2 4-{5-[Bis-(2-chloro-ethyl)-amino]-1-methyl-1H-benzoimidazol-2-yl}-butyric acid isopropyl ester BENDROFLUMETHIAZIDE "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Biapenem a) 6-((4R,5S,6S)-6-((R)-1-Hydroxyethyl)-4-methyl-2-((4-nitrobenzyloxy)carbonyl)-7-oxo-1azabicyclo[3.2.0]hept-2-en-3-ylthio)-6,7-dihydro-5H-pyrazolo[1,2-a][1,2,4]triazo-4-ium chloride 189 Biapenem 190 191 192 193 194 Bicalutamide Bicalutamide Bicalutamide Bicalutamide Bicalutamide 195 b) 6N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(2-fluorophenyl)sulfonyl]-2-hydroxy-2methyl-propanamide. Bicalutamide c) N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfinyl]-2-Acetyloxy-2methylpropanamide. d) 4-Fluorobenzene sulphonic acid. e) 2,3-Epoxy-2-mehyl-N-[4-Cyano-3-(trifluoromethyl)phenyl]propanamide. Bicalutamide Bicalutamide Bicalutamide 200 f) N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl]thio]-2-hydroxy-2methylpropanamide Bicalutamide g) N-[4-Cyano-3-(trifluoromehtyl)phenyl]-3-[(3-fluorophenyl)sulfonyl]-2-hydroxy-2methylpropanamide. Bicalutamide h) N-[4-Cyano-3-(trifluoromehyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2methylpropanamide. Bicalutamide i) N-[4-Cyano-3-(trifluoromehyl)phenyl]-3-[(4-fluorophenyl)sulfinyl]-2-hydroxy-2methylpropanamide. Bicalutamide j) N-[4-Cyano-3-(trifuoromethyl)phenyl]-3-[(phenyl)sulfonyl]-2-hydroxy-2methylpropanamide. k) 4-Amino -2-(trifluoromethyl) benzonitrile. L) 4-Amino -3-(trifluoromethyl) benzonitrile. m m ) 4-Amino -3-(trifluoromethyl)benzonitrile. Bicalutamide Impurity B Bicalutamide Impurity E Bicalutamide Impurity H a) N-((S)-1-carbamoyl-2-phenylethyl)pyrazine-2-carboxamide. b) N-(Pyrazine-2-ylcarbonyl)-L-Phenylalanine. 201 202 203 204 205 206 207 208 209 210 211 212 a) N-[4-Cyano-2-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfinyl]-2-hydroxy-2-methylpropanamide. Bicalutamide 196 197 198 199 b) (2S,3R)-2-(1S,2R)-1-carboxy-2-2hydroxypropyl)-4-(6,7-dihydro-5H-pyrazolo[1,2a][1,2,4]triazol-4-ium-6-ylthio)-3-methyl-3,4-dihydro-2H-pyrrole5-carboxylate. Bicalutamide Impurity A Bicalutamide Impurity C Bicalutamide Impurity F Bicalutamide Impurity J Bicalutamide Bicalutamide Bicalutamide Bicalutamide Bicalutamide Bicalutamide Bortezomib Bortezomib "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Bortezomib c) [(1(R)-3-Methyl-1-[[(2R)-1-oxo-3-phenyl-2[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronicacid.) Bortezomib d) N(S)-(1-(1(R)-hydrocy-3-methyl butyl amino)-1-oxo-3-phenyl propane-2-yl)pyrazine2-carboxamide. Bortezomib e) N(S)-(1-(1(S)-hydroxy-3-methyl butyl amino)-1-oxo-3-phenylpropane-2-yl)pyrazine2-carboxamide. Bortezomib Impurity - 4 Allyl Imp Keto Imp 2- chloro allyl Imp a) 4-(1,1-Dimethylethyl)benzenesulfonamide. 213 214 215 216 217 218 219 220 Bortezomib Bortezomib Bortezomib Bortezomib Bosentan Monohydrate Bosentan Monohydrate 221 Bosentan Monohydrate c) 4-(1,1-Dimethylethyl)-N-[6-chloro-5-(2-methoxy-phenoxy)-[2,2’]bipyrimidinyl-4-yl]benzene sulfonamide. Bosentan Monohydrate d) 4-(1,1-Dimethylethylethyl)-N-[6-hydroxy-5-(2methoxy-phenoxy)-[2,2’]bipytimidinyl-4yl]benzene sulfonamide. Brinzolamide Related Compound A Brinzolamide Related Compound B Impurity 1 (4-chloro-3-nitro-5-sulphamoyl benzoic acid-) Impurity 2 (3-amino-4-phenoxy-5-sulphamoyl benzoic acid-) Impurity 3 (3-nitro-4-phenoxy-5-sulphamoyl benzoic acid-) Impurity 4 (Propyl analogue-) Impurity 5 (Butyl-3-(butylamino)-4-phenoxy-5-sulphamoyl benzoate-) 2-(Tert-butylamino)-4'-chloropropiophenone hydrochloride = RC-A 2-(Tert-butylamino)- 3'-bromopropiophenone hydrochloride 1-(3-Chlorophenyl)-2-hydroxy-1-propanone 2-(Tert-butylamino) propiophenone hydrochloride (RC-D) 1-(3-Chlorophenyl)-1,2-propanedione 3'-Chloropropiophenone 2-Bromo-3'-chloropropiophenone 3-Chlorobenzoic acid 3-Chlorobenzoic acid 2-(tert-Butylamino)-2'-chloropropiophenone HCl 2-(tert-Butylamino)-3',5'-Chloropropiophenone HCl 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 b) 1,2-bis[[5-(2-mehyoxy-phenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]-4-tert-butyl-benzene sulfonamide]ethanediol. Brinzolamide Brinzolamide Bumetanide Bumetanide Bumetanide Bumetanide Bumetanide Bupropion Bupropion Bupropion Bupropion Bupropion Bupropion Bupropion Bupropion Bupropion Bupropion Bupropion "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 242 243 244 245 246 Buspirone Buspirone Buspirone CandesartanCilexetil CandesartanCilexetil CandesartanCilexetil Buspirone Impurity E Buspirone Impurity J Buspirone Impurity K Triphenyl methane a) Triphenyl methanol CandesartanCilexetil c)2-hydroxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4yl]mehtyl]-1[[(Cyclohexyloxy)carbonyl]oxy)carbonyl]ethyl ester 1H-Benzimidazole-7-carboxylate. CandesartanCilexetil d) Ethyl 2-ethoxy-1-[[2’-(1H-tetrazole-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1Hbenzimidazole-7-carboxylate. CandesartanCilexetil e)2-Ethoxy-1-[[2’-(1H-tetrazole-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-Benzimidazole-7-carboxylic acid. CandesartanCilexetil f) 1-(Cyclohexyloxycarbonyloxy)ethyl2-ethoxy-1-[[2’-(N-tryphenylmethyltetrazole-5-yl)biphenyl4-yl]mehtyl]benzimidazole-7-carboxylate. Capecitabine related compound A Capecitabine related compound B Capecitabine related compound C 2’,3’-Di-O-acetyl-5’-deoxy-5-fluorocytidine a) 5’-Deoxy-5-fluorouridine.(USPRCB) b) 5’3-Di-O-acetyl-5’deoxy-5-fluorocytidine. c)5 5’-Deoxy-5-fluoro-N4-(2-Methyl-1-butyloxycarbonyl)cytidine. d) 5’Deoxy-5-fluoro-N4-(3-methyl-1-butyloxycarbonyl)cytidine. e) 5’-Deoxy-5-fluorocytidine.(USPRCA) 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 Capacetabine Capacetabine Capacetabine Capacetabine Capecitabine Capecitabine Capecitabine Capecitabine Capecitabine Capecitabine carbamazepin carbamazepine Carglumic acid Carglumic acid Cefprozil Cefprozil Cefprozil Cefprozil Cefprozil b) 2-Hydroxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]mehtyl]-1H-Benzimidazole-7carboxylic acid. 10,11-dihydro-10-hydroxy carbamazepine 10-methoxy carbamazepine a) 3-(2, 5-Dioxoimidazolidin-4-yl) propanoic acid. b) Glutamic acid. a) (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid. b) [R-(Z)][4-Hydroxy-ά-[3-methoxy-1-methyl-3-oxo-1-propenyl)amino]]-benzeneacetic acid. c) 7-Amino-3-(E-propen-1-yl)-3-cephem-4-carboxylic acid. d) 7-Amino-3-(Z-propen-1-yl)-3-cephem-4-carboxylic acid. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 271 272 273 274 275 276 277 278 279 280 281 Cefuroxime Celecoxib Celecoxib Celecoxib Celecoxib Celecoxib Celecoxib Celecoxib descarbamoyl cefuroxime a) 4-[4-(4’-Methylpenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzensulfonamide. b) 4-[2-hydroxy-5-(4’Methylphenyl)-3-(tri fluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide. c) [5-(4-Methylphenyl)-3-tri fluoromethyl-1H-pyrazole]. d) 4-[5-(3’Methylphenyl)-3-(tri fluoromethyl)-1H-Pyrazol-1-yl] benzene sulfonamide. e) 4-Methylacetophenone. f) 4-[-(2’Methylphenyl)-3-(tri fluoromethyl)-1H-pyazol-1-yl]benzene sulfonamide. Celecoxib Celecoxib Celecoxib Celecoxib Related Compound A Celecoxib Related Compound B CELECOXIB HBSH IMPURITY 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 Celecoxib Celecoxib Celecoxib CEPHALEXIN CEPHALEXIN CEPHALEXIN CEPHALEXIN CEPHALEXIN CEPHALEXIN CEPHALEXIN CEPHALEXIN CEPHALEXIN Cetirizine impurity Cetirizine impurity Cetirizine impurity Cetirizine impurity Cetirizine impurity Cetirizine impurity Cetirizine impurity Cetirizine impurity CETRIZINE CETRIZINE CETRIZINE (4-[5-(2-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide) Ortho isomer Celecoxib 4-Sulphonamido phenyl hydrazine hydrochloride 4-{2-[1-(4-methylphenyl) ethlidene]hydrazine}benzenesulfonamide CEPHALEXIN IMPURITY-C CEPHALEXIN IMPURITY-D CEPHALEXIN IMPURITY-E CEPHALEXIN IMPURITY-J CEPHALEXIN IMPURITY-K CEPHALEXIN SULFOXIDE L-CEPHALEXIN CEPHALEXIN PHENYLGLYCIN CEPHALEXIN DIKETOPIPERAZINE e) Cetirizine Impurity A e) Cetirizine Impurity B e) Cetirizine Impurity C e) Cetirizine Impurity D e) Cetirizine Impurity E e) Cetirizine Impurity F e) Cetirizine Impurity G e) Cetirizine Impurity H CETRIZINE ETHYL ESTER CETRIZINE DI HCL Cetirizine Lactose ester "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 305 306 CHLOROPROPIOPHENONE Chlorthalidone Cilazapril 2-BROMO-3-CHLOROPROPIOPHENONE Chlorthalidone Related compound A Cilazapril b)Ethyl(1S,9S)-9-[[(S)-1-(ethoxycarbonyl-3-phenylpropyl]amino-10-oxooctahydro-6Hpyridazino[1,2-a][1,2]diazepine-1-carboxylic Acid.(EPB) a) (R)-(+)-1-(1-Naphthyl)ethylamine. 307 308 309 Cinacalcet Hydrochloride Cinacalcet Hydrochloride 310 Cinacalcet Hydrochloride 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 Cinacalcet Hydrochloride Ciprofloxacin Ciprofloxacin Ciprofloxacin Ciprofloxacin Ciprofloxacin Citalopram Hydrobromide Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin Clarithromycin CLOMIPRAMINE a) Ethyl(1S,9S)-9-[[S)-1-(ethoxycarbonyl-3-phenylpropyl]amino]-10pyridazino[1,2,-a][1,2]diazepine-1-carboxylate(EPC) oxooctahydro6h- b) (R)-α-Methyl-N-[3-[3-(trifluoromethyl)phenyl]methyl]-1-napthalenemethane amine hydrochloride. c) (αS)- α-Methyl-N-[3-[3-(trifluoromethyl)phenyl]propyll]-1-napthalenemethanamine hydrochloride. d)3-(3-(Trifluoromethyl)phenyl)popanal. Ciprofloxacin Impurity E Ciprofloxacin Impurity F 2-butyl-3-(4-hydrox y-3,5-diiodobenzoyl) benzofuran BPCRS (impD) Amiodarone impurity E EP Ciprofloxacin ethylenediamine Analog a) 4-[(4-Dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl]-3-(hydroxymethyl]benzonitrile. Clarithromycin Impurity I a) Clarithromycin impurity C b) Clarithromycin impurity D c) Clarithromycin impurity M d) Clarithromycin impurity N e) Clarithromycin impurity I f) Clarithromycin impurity J g) Clarithromycin impurity L h) Clarithromycin impurity O i) Clarithromycin impurity G j) Clarithromycin impurity H Clarithromycin Impurity D Clarithromycin Impurity H Clarithromycin Impurity Q Clarithromycin Related Compound A CLOMIPRAMINE N-OXIDE "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 CLOMIPRAMINE Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Clopidogrel Hydrochloride Clopidogrel Hydrochloride DESMETHYLCLOMIPRAMINE HCL Clopidogrel USP related compound A Clopidogrel USP related compound B Clopidogrel USP related compound C a) 2-Bromo-2-(2-chlorophenyl)acetic Acid b) 2-Chloromandelic Acid Methyl Ester c) R-Clopidogrel Carboxylic Acid d) S-Clopidogrel Carboxylic Acid e) Clopidogrel Related Compound ‘A’ f) Clopidogrel Related Compound ‘B’ g) Clopidogrel Related Compound ‘C’ h) Clopidogrel Iminium impurity i) Clopidogrel EP impurity 'D' Mol. j) S-Clopidogrel N-Methyl Impurity I k) Clopidogrel Coupled amine Mol. l) 2-Thiophene ethanol a) [(+)-(S)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]-pyridine-5(4H)-acetic acid.] (USPRCA) Clopidogrel Clopidogrel Clopidogrel Clotrimazole Colchicine Curcumin Cyclizine Cyclizine Cyclobenzaprine Cyclobenzaprine Cyclobenzaprine Cyclobenzaprine Cyclobenzaprine Cyclobenzaprine Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride b) [methyl(-)-(R)-(o-chlorophenyl)6,7-dihydrothieno[3,2-c]-pyridine-5(4H)-acetate,hydrogen sulfate].(USPRCC) Clopidogrel Related Compound A Clopidogrel Related Compound B Clopidogrel Related Compound C Clotrimazole Related compound A N-deacetyl Colchicine Curcumin Sulphate Cyclizine impurity A Cyclizine impurity B Amitriptyline Cyclobenzaprine N Oxide Cyclobenzaprine Related compound A USP Cyclobenzaprine Related compound B USP Cyclobenzaprine HCL usp Dibenzocycloheptenone a) 5-(3-Dimehylaminopropyl)-5-hydroxydibenzo[a,e]cyclo heptatriene. b) 5H-Dibenzo[a,d]cycloheptaten-5-ol. (CBHRC02) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 CYCLOHEXANONE Cyclophosphamide Cyclophosphamide Cyclophosphamide Cyclophosphamide CYCLOHEXANONE Monohydroxy Cyclophosphamide Monohydroxy Melphalan Cyclophosphamide HPLC Impurity -B . a) Bis -(2-Chloroethyl)amine hydrochloride.(USPRCA) Dabigatran Etexilate N-Oxide (impurity N) a)3-Amino pyridin b)2-Amino pyridin. c)3-Nitro pyridin N-oxide. d)4-Nitro pyridin N-oxide. e)3-Nitro pyridin. a) (S)-α,α-Diphenyl-3-pyrrolidin acetamide tartarate, Dabigatran Dalfampridine Dalfampridine Dalfampridine Dalfampridine Dalfampridine Darifenacin hydrobromide Darifenacin hydrobromide b) (3R)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl)- α,α-diphenyl-3-pyrrolidin acetamide hydrobromide. a) 4-Amino-N-(2R,3S)(3-amino-2-hydroxy-4-phenyl-butyl)-N-isobutyl-benzenesulfonamide. Darunavir Darunavir b) [(1S,2S)-3[[(4-Amino-phenyl-)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]-furan-3-yl ester. a) 2-(6-Chloro-2-methylpyridine-4-ylamino)-N-(2-Chloro-6Methylphenyl) thiazole -5- carboxamide. Decylamine HCl Di Decylamine HCl Dasatinib Dasatinib Decylamine Decylamine Desloratadine a)11-[N-Methyl-4-piperidylidene]-8-chloro-6-,11-dihydro-5Hbenzo[5,6]cyclohepta[5,6]cycloheptal[1,2-b]pyridine, 388 Desloratadine 389 390 391 392 393 394 395 396 397 398 b) 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cycloheptal[1,2-b]pyridin-11-ylidene)-1-piperidine carboxylic acid ethylester. a)1-[2-(Dimethylamino)-1-(4-benzyloxyphenyl)ethyl]cyclohexanol. Desvenlafaxine succinate Dexlansoprazole Dexlansoprazole Dexlansoprazole Dexpramipexole dihydrochloride Dexpramipexole dihydrochloride Dexpramipexole dihydrochloride Dexpramipexole dihydrochloride Dexpramipexole dihydrochloride a) 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl-1H-benzimidazole1’-oxide. b) 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]thio]-1H- benzimidazole. c) 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfonyl-1H-benzimidazole a) b) a) b) c) (R)-N2,N6-Dipropyl-4,5,6,7-terthydrobenzo[d]thiazol-2,6-diamine. (6R)-6-N-ethyl-4,5,6,7-tertrahydro-1,3-benzothiazol-2,6-diamine dihydrochloride. (6R)-4, 5, 6, 7-tetrahydro-1,3-benzothiazole-2,6-diamine. (S)-4,5,6,7-terahydro-N-6-propyl-2,6-benzothiazolediamine dihydrochloride. c) N-(6R)-2-Amino-4, 5, 6, 7-tetrahydro-1,3-benzothiazole-6-yl]propanamide . "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 399 400 401 402 403 404 405 406 407 408 409 410 411 412 Dextroemthorphan Diacerein Diacerein Diclofenac Diclofenac Diclofenac sodium Diclofenac Diclofenac Diclofenac Diclofenac Diclofenac Didanosine Didanosine Didanosine Didanosine 413 Didanosine 414 d) 9-(2,3-Dideoxy-beta-D-glycero-pent-2-enofuranosyl)-1,9-dihydro-6H-purin-6-one(OR) 2’,3’Dideoxy-2’,3’-didehydroinosine. (EP-F) a) Benzenepropanoic acid, β-[[(1,1-dimethylethoxy) carbonyl]amino]-α-hedroxy(2Ar,4S,4As,6R,9S,11S,12aR,12S,12bS)-12b-(acetyloxy)-12-(benzoyloxy)2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-6,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-4[[(2,2-dichloroethoxy)carbonyl]oxy]-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl. Didanosine b)1,7α-dihydroxy-9,10-dioxo-5β,20-epoxytax-11-ene-2α,4,13α-tetrayl4-acetate2-benzoate13[(2R,3S)3-[[(1,1-dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate].(10dehydroxy-10-oxo-7epi-docetaxel) (EP-D) Didanosine c) 1,7β-dihydroxy-9,10-dioxo-5β,20-epoxytax-11-ene-2α,4,13α-triyl4-acetate2-benzoate13[(2R,3S)3-[[(1,1-dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate].(10dehydroxy-10-oxodocetaxel).(EP-B) DIHYDROARTEMISININ ARTEMISININ DIPHENHYDRAMINE REL COMP A Diphenhydramine Impurity A Diphenhydramine Impurity B Diphenhydramine Impurity C Diphenhydramine Impurity D Diphenhydramine Impurity E Diphenhydramine N-oxide 415 416 417 418 419 420 421 422 423 424 425 Dextromethorphan Hydrobromide Impurity- D impurity 1 ( Hydrolysis -1) impurity- 2 ( Hydrolysis -2) Diclofenac Imp A Diclofenac Imp B a)1-(2,6-Dichlorophenyl)indolin-2-one. (USPRCA) Diclofenac related compound A Diclofenac related compound A Diclofenac Ep Impurity_B Diclofenac Ep Impurity_C Diclofenac Ep Impurity_E a) Inosine. (EP-B) b) Hypoxanthine. (EP-A) c) 5’-O-Acetyl-2’,3’-dideoxy inosine. DIHYDROARTEMISININ DIHYDROARTEMISININ DIPHENHYDRAMINE Diphenhydramine Diphenhydramine Diphenhydramine Diphenhydramine Diphenhydramine Diphenhydramine "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 Dipyridamole Dipyridamole Dipyridamole Dipyridamole Dipyridamole Dipyridamole Dipyridamole Docetaxel trihydrate Docetaxel Docetaxel Docetaxel Docetaxel Docetaxel Domperidone Domperidone Domperidone Domperidone Domperidone Domperidone DONEPEZIL DONEPEZIL DONEPEZIL DONEPEZIL DONEPEZIL Donepezil hydrochloride Donepezil hydrochloride Donepezil hydrochloride Donepezil hydrochloride Donepezil hydrochloride Donepezil hydrochloride Donepezil hydrochloride Dipyridamole Impurities –A ( EP ) Dipyridamole Impurities –B( EP ) Dipyridamole Impurities –C( EP ) Dipyridamole Impurities –D( EP ) Dipyridamole Impurities –E( EP ) Dipyridamole Impurities –F( EP ) Dipyridamole Impurities –G( EP ) d)1,7α,10 β-Trihydroxy-9-oxo-5β,20-epoxytax-11-ene-2α,4,13α-triyl4-acetate2-benzoate13[(2R,3S)-3-[[(1,1-dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate].(7-epidocetaxel). (EP-C) 6-oxo-docetaxel 10 Deacetyl Baccatin III 7 Epidocetaxel impurity 7-Epi-10-oxo-docetaxel 10-oxo-docetaxel Domperidone Impurity-A Domperidone Impurity-B Domperidone Impurity-C Domperidone Impurity-D Domperidone Impurity-E Domperidone Impurity-F DONEPEZIL-PYRIDINE ANALOG DONEPEZIL-DESBENZYL DONEPEZIL DONEPEZIL-BENZYL BROMIDE DEHYDRO DEOXY DONEPEZIL DEOXY DONEPEZIL a) 2,3-Dihydro-5,6-dimethoxy-2-[(4-pyridinyl)methyl]-1H-inden-1 one,Hydrochloride. b) 1-Benzyl-4-[3-(benzyloxy)-5,6-dimethoxy-1H-2-indenyl]methylpiperidine,Hydrochloride. c) 1-Benzyl-4-[(5,6-dimethoxy-1H-inden-2-yl)methyl]piperidine,hydrochloride.( d) 5,6-Dimethoxy-2-(4-pyridyl)methyl-indan-1-one. e) 2,3-Dihydro-5,6-dimethoxy-2-[(4-piperidinyl)methyl-1-one-hydrochloide. f) 1-Benzyl-4-[(5,6-dimethoxy-2,3-dihydro-1H-inden-2-yl)methyl]piperdine hydrochloride. g) 1,1-Dibenzyl-4-[(5,6-dimethoxy-1-oxo-2,3-dihydro-1H-inden-2-yl)methyl]piperidinium bromide. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Doripenem monohydrate 457 a) 4-Nitrobenzyl(4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-3-[[(3S,5S)-1-(4nitrobenzyloxycarbonyl)-5-(sulfamoylaminomethyl)pyrrolidin-3-yl]thio]-7-oxo-1azabicyclo[3.2.0]hept-2-ene-2-carbxylate. Doripenem monohydrate 458 b) 4-Nitrobenzyl(2S,4S)-2-{[(aminosulfonyl)amino]methyl}-4-mercaptopyrrolidine-1-carboxylate Doripenem monohydrate 459 460 461 462 Dorzolamide Dorzolamide Dorzolamide Dorzolamide hydrochloride 463 Dorzolamide hydrochloride 464 Dorzolamide hydrochloride 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 Doxazosin mesylate Doxazosin mesylate Doxazosin mesylate Doxylamine succinate Doxylamine succinate Doxylamine succinate Drotaveraldine Duloxetine Duloxetine Duloxetine Duloxetine hydrochloride Duloxetine hydrochloride Duloxetine hydrochloride Duloxetine hydrochloride Duloxetine hydrochloride Dutasteride Dutasteride Dutasteride Dutasteride c) 4-Nitrobenzyl(4R,5R,6S)-3-[(diphenoxy)phosphoryl oxy]-6-[(IR)-1-hydroxyethyl]-4-methyl-7oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate. Dorzolamide Hydrochloride RelatedCompound A Dorzolamide Related Compound B DORZOLAMIDE IMPURITY C a) (4R,6R)-4-(Ethylamino)-5,6-dihydro-6-mehtyl-4H-thieno[2,3-b]-thiopyran-2-sulfonamide-7,7dioxide hydrochloride. (USPRCA) (R,R-isomer-92% ) (S,S –isomer-98%) b)(4R,6S)-4-(Ethylamino)-5,6-dihydro-6-mehtyl-4H-thieno[2,3-b]-thiopyran-2-sulfonamide-7,7dioxide hydrochloride . c) (4S,6S)-4-(Acetylamino)-5,6,6-dihydro-6-mehtyl-4H-thieno[2,3-b]-thiopyran-2-sulfonamide7,7-dioxide a) N-(2,3-Dihydro-1,4-benxodiaxin-2-yl-carbonyl)piperazine. b) 4-amino-2-chloro-6,7-dimethoxy quinazoline. (EP-F) c) 4-amino-2-(1-Piperazinyl)-6,7-dimethoxy quinazoline. (EP-F) a) (1RS)-1-phenyl-1-(pyridin-2-yl)ethanol. b) N,N-dimethyl-2-[1(RS)-1-phenyl-1-(pyridine-4-yl)ethoxy]ethanamine. c) phenyl (pyridine-2-yl)methanone(2-benzoylpyridine). Drotaveraldine Duloxetine Hydrochloride Related Compound C – Related Compound A – a) 1-Naphthol. b) (R,S)-N-Methyl-3-(1-Naphthyloxy)-3-(3-thienyl)propanamine. c) (S)-N-Methyl-N-phenyloxy carbonyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine. d) (R)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine. Dutasteride Impurity A Dutasteride Impurity B Dutasteride Impurity C Dutasteride Impurity E "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 485 486 487 488 489 490 491 492 493 494 495 496 497 498 Dutasteride Efaverinz Efaverinz Efaverinz Efaverinz Efaverinz Efaverinz Efaverinz Efaverinz Eletriptan hydrobromide. Eltrombopag olamine Eltrombopag olamine Eltrombopag olamine Eltrombopag olamine Emtricitabine 499 Emtricitabine 500 501 502 503 504 505 506 507 508 509 510 Emtricitabine Emtricitabine Emtricitabine Emtricitabine Emtricitabine Emtricitabine Emtricitabine Emtricitabine Emtricitabine Enalapril Dutasteride Impurity F a) (S)-6-Chloro-4-pent-1-inyl-4-trifluoro methyl-1,4-dihydrobenzo[d]-1,3-oxazin-one. b) (S)-6-chloro-4-cylopropyl ethinyl-1-(4-methoxybenzyl)-4-trifluoromethyl-1,4-dihydrobenzo[d]1,3-oxazin-2-one. c) (S)-6-Chloro-4-trifluoromethyl-4-cyclopropylethenyl-1H-benzo[d]-1,3-oxanzin-2-one. d) 6-chloro-1-(1S)-camphanoyl-4-4S-(cyclopropylethenyl)-trifluoromethyl-1,4-dihydro-2H-3,1benzoxazin-2-one. (e) (S) -5-Chloro-α-(cyclopropylethynyl)-2-amino- α -(trifluoromethyl)-benzene methanol. (f) P-Nitrophenol. g) (4RS)-6-Chloro-4-(cyclopropylethenyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-Benzoxazin-2one. (R-Isomer-50.0%)(S-Isomer-50.0%) h) 6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline. a) 3-[[2S)-1-mehyl-2-pyrrolidinyl]mehyl]-5-[2-(phenyl-sulfonyl)ehyl]-1H-indole. A) (Z)-Methyl-3’-(2-(1-(3,4-dimethylphenyl)-3-mehtyl-5-oxo-1H-pyrazol-4-(5H)yledene)hydrazine)-2’-hydroxy biphyenyl-3-carboxilate. B) 2-(3, 4-dimehtylphenyl)-5-mehtyl-1H-Pyrazol-3(2H)-One. A) (Z)-Ethyl-3’-(2-(1-(3,4-dimehtylphenyl)-3-mehtyl-5-0xo-1H-pyrazol-4-(5H)ylidenehydrozinyl)2’-hydorxy biphenyl-3-carboxilate. B) 2’-Hydroxy-3’-aminobiphenyl-3-carboxylic acid. a) 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymehtyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone,Sosxide. b) (2R,5S)-5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-[1,3]oxathiolane-2-carboxylic acid(1R,2S, 5R)-methyl ester. c) (5S)-5-(4-Amino-5-fluoro-2-oxopyrimidine-1(2H)-yl)-1,3-oxothiolane-2-carboxylic acid. d) 5-Fluoro-1-(2-(hydroxymethyl)-1,3-oxothiolan-5-yl)pyrimidine-2,4(1H,3H)-dione. (OR) 2,3’-dideoxy-5-fiuoro-3’-thiouridine. e) 4-Amino-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-Pyrimidinone.(-)(cis – Isomer -50..0% & (+)(cis –Isomer -50.0% Emtricitabine Diastereomer Carboxylic Acid Impurity Emtricitabine Oxide Impurity FTU Impurity Emtricitabine Diastereomer Ethoxy Carbony Phenyl Propyl Alanine "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 Entacapone Entacapone Entacavir Eprosartan mesylate Eprosartan mesylate Eprosartan mesylate Eprosartan mesylate Erlotinib hydrochloride Erlotinib hydrochloride Erlotinib hydrochloride Escitalopram oxalate Escitalopram oxalate Escitalopram oxalate Eslicarbazepine acetate Eslicarbazepine acetate Eslicarbazepine acetate Esomeprazole Esomeprazole Esomeprazole Esomeprazole Esomeprazole ESZOPICLONE Ethionamide Etoricoxib Etoricoxib Etravirine Etravirine Etravirine a) 2-Cyano-N,N-diethylacetamide. b) (2E)-2-Cyano-3-(3-methoxy-4-hydroxy-5-nitro phenyl)-N,N-Diethyl-2-propenamide A) 2-Amino -9-((1S, 3R, 4S)-3-(benzyloxymethyl)-4-hydroxy-2mehtylenecyclophenytl)-9H-purin-6-ol. a) 2-Carbethoxy-3-(2-thienyl)sodiumpropanoate. b) 4-[[2-butyl-5-formyl-1H-imidazol-1-yl]mehyl]benzoic acid. c) 4-((2-butyl-5-((E)-2-carboxyvinyl)-1H-Imidazol-1-yl)mehyl)benzoic acid mesylate. d) 4-((2-butyl-5-(2,2-dicarboxyvinyl)-1H-imidazol -1-yl)methyl)benzoic acid. a) 6,7-Bis(2-Methoxyethoxy)-N-(3-ethylphenyl)quinazolin-4-amine. b) 6,7-Bis(2-Methoxyethoxy)-N-(3-ethylphenyl)-N-(2-methoxyethyl)quinazolin-4-amine. c) 4-Chloro-6,7-bis(2-methoxyethoxy)quinazoline. a) 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5- carbonitrile –NOxide. b) 4-[(4-dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl]-3-(hydroxmethyl)benzonitrile. c)1(R)-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran carbonitrile oxalate a)S(+)10,11-dihydro-10-hydroxy-5H-dibenzo[b,f]azepine-5-carboxamide. b)10-Oxo-10,11- hydro-5H-dibenzo[b,f]azepine-5-carboxamide. c)(R)-(-)-10-Acetyl-10,11-dihydro-5H- dibenzo[b,f]azepine-5-carboxamide. a)5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridine-2-yl)methyl]sulphinyl]1H-benzimidazole 1’0xide b)5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridine-2-yl)methyl]sulfonyl]1H-benzimidazole. c)5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridine-2-yl)methyl]thio]-1H-benzimidazole. d) (R)-5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridine-2-yl)methyl]sulfinyl]-1H-benzimidazole. e)2-((3,5-Dimethylpyridin-2-yl)methylsulfinyl)-5-methoxy-1H-benzo[d]imidazole. ESZOPICLONE IMPURITY-B Ethionamide Sulfoxide a) 2-Chloro-1,3-bis(dimethylamino)trimethinium hexafluoro phosphate b) 1-(6-mehyl pyridine-3-yl)-2-[(4-methyl sulphonyl)phenyl]ethanone. a) 4-(6-Amino-5-bromo-2-[4-(aminocarbonyl)anilino]pyrimidin-4-yloxy)-3,5-dimethyl benzamide. b) 4-(6-Amino-5-bromo-2-[4-(cyanophenylamino)pyrimidin-4-yloxy) 3,5-dimethyl benzamide. c) 4-(6-Amino-5-bromo-2-[4 -(cyanophenylamino)pyrimidin-4-yloxy) 3,5-dimethyl benzanitrile. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Etravirine d) 4-[2-(4-Cyanoanilino)-6-(4-cyano-2,6-dimethylphenoxy)-4-pyrimidinyl]oxy-3,5dimethylbenzonitrile. Etravirine e) 4-[5-Bromo-2-(4-cyanoanilino)-6-(4-cyano-2,6-dimethylphenoxy)-4-pyrimidinyl]oxy-3,5dimethylbenzonitrile. f) 4-[[6-chloro-5-bromo-2-[(4-cyanophenyl amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile. g) 4-(6-chloro-2-(4-cyanophenyl amino) pyrimidin-4-yloxy)-3,5-dimethylbenzonitrile. 539 540 541 542 Etravirine Etravirine Ezetimibe 543 Ezetimibe 544 545 Ezetimibe Ezetimibe 546 Ezetimibe 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 Famciclovir Famciclovir Famciclovir Famciclovir Febantel Febuxostat Febuxostat Felbamate Felodipine Felodipine Felodipine Felodipine Felodipine Fenofibrate Fenofibrate Fenofibrate Fenofibrate Fenofibrate a) (3R,4S)-4-(4-(benzyloxy)phenyl)-1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3oxopropyl]azetidin-2-one. b)(3R,4S)-1-(4-fluorophenyl)-3-[3-(4-fluorophenyl)-3-(S)-hydroxypopyl]-4-(4-benzyloxyphenyl)2-azetidinone. c) (2R,5S)-2-(4-Hydroxybenzyl)-N,5-bis(4-fluorophenyl)-5-hydroxypentanamide. d) (3R,4S)-1-(4-fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-hydroxypopyl]-4-(4hydroxyphenyl)azetidin-2-one. e) (2R,3R,6S)-N,6-bis(4-fluorophenyl)-tetrahydro-2-(4-hydroxyphenyl)-2H- pyran-3carboxamide. a) 2-Amino-9(4-hydroxy-3-(hydroxyl methyl)butyl)-3H-purin-6-one. b) 2-[2-(2-Amino-9H-purin-9-yl)ehtyl]-propane-1,3-diol hydrochloride. c)2-[2-(2-Amino-6-chloro-9H-purin-9-yl)ethyl]-1,3-propane dilo diacetate. d) 4-(2-Amino-9HPurin-9-yl)-2-(hydroxyl methyl)butyl acetate. e) 2-(Acetoxymethyl)-4-(2-amino-9H-Purin-9-yl)butyl propionate. 2-methoxy-N-[2-nitro-5-(phenylsulfanyl) phenyl] acetamide) a) 2-(3-Carbamoyl-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylicacid. b) Ethyl2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylicacid. a) 2-phenyl-1,3-propanediol. Impurity B Impurity C Felodipine Imp A Felodipine Imp B Felodipine Imp C a) [(4-chlorophenyl)(4-hydroxyphenyl )methanaone].(USPRACA) b) (2-(4-(4-chlorobenzoyl) phenoxy)-2-methylpropanoic acid. (USPRCB) (3RS )-3-[4-(4-Chlorobenzoyl) phenoxy]butan-2-one Methyl 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoate Ethyl 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoate (4-Chlorophenyl)[4-(1-methylethoxy) phenyl]methanon "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 Fesoterodine fumarate Fesoterodine fumarate Fesoterodine fumarate Fesoterodine fumarate Fesoterodine fumarate Fesoterodine fumarate Fesoterodine fumarate Fexofenadine Fexofenadine Fexofenadine Imp- (A) Fexofenadine Imp- (B) Finasteride Finasteride Finasteride Finasteride Finasteridie Finasteridie Finasteridie Fingolimod HCL Fingolimod HCL Fingolimod HCL Fluvastatin sodium 587 594 2-((R)-3-(Diisoprpylamino)-1-phenypropyl-4-(hydroxymethyl) phenol. (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-methylphenol. 2-((R)-3-(Diisoprpylamino)-1-phenypropyl-4-(methylphenyl isobutyrate. 2-((R)-3-(Diisoprpylamino)-1-phenypropyl)phenyl isobutyrate. (R)-3-(3-Diisopropylamino)-1-phenylpropyl)-4-(isobutyryloxy) benzylisobutyrayte, f) Isobutyic acid 2-((S)-3-diisopropylammonium-1-phenylpropyl)-4-Hydroxymethyl) phenyl ester hydrogen furmarate. g) (R)-2-(3-Diisopropylamino)-1-phenylpropyl)-4-formylphenyl isobutyrate. Fexofenadine Related Compound A Fexofenadine Related Compound B a) (5α,17β)-N-(1,1-dimethyl ethyl)-3-oxo-4-aza androstane-17carboxamide. b) (5α,17β)-N-(cyclohexyl)-3-oxo-4-aza-5-androst-1-ene-17-carboxamide. c) (5α,17β)-Methyl-3-oxo-4-aza androst-1-ene-17-carboxylate. d) 1,3-Dicyclohexyl urea. a)(5α,17β)-N-(1,1-dimethyl ethyl)-3-oxo-4-aza androstane-17carboxamide. b) (5α,17β)-N-(cyclohexyl)-3-oxo-4-aza androstane-1-ene-17-carboxamide. c) (5α,17β)-Methyl-3-oxo-4-aza androstane-1-ene-17-carboxylate. a)2-Amino-4-(4-octylphenyl)butan-1-ol. b)N-(1-Hydroxy-2-(hydroxymethyl)-4-(4-octylphynyl)butan-2-yl)acetamide. c)N-(1-Hydroxy-4-(-octylphynyl)butan-2-yl)acetamide. a) [R*,R*-(E)]-±-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2yl]-3, 5-dihydroxy6-heptenoic acid monosodium salt. Fluvastatin sodium b) Methy (±)-erythro-E-3,5-dihydroxy-7-[3’-4”-fluorophenyl)-1’-(1”-methylethy)-indol2’-yl]hept-6-enoate. Fluvastatin sodium a) Methyl(±)-erthro-E-3,5-dihydroxy-7-[3’(4’-fluorophenyl)-1-(1’methylethyl)-indol-2’-yl]hept-6enoate. Fluvoxamine Impurity C Fluvoxamine Impurity D Fluvoxamine Impurity I Fluvoxamine Impurity G 588 589 590 591 592 593 a) b) c) d) e) Fluvoxamine Fluvoxamine Fluvoxamine I Fluvoxamine Impurity G Fosamprenavir calcium a)3-Amino-1-(4-amino-N-isobutylphenylsulfonamido)-4-phenylbutan-2-yl dihydrozen phosphate. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Fosamprenavir calcium b)(S)-tetrahdrofuran-3-yl (2S,3R)-4-(N-isobutyl-4-nitrophenyl sulphonamido)-1-phenyl-3(phosphonooxy)butan-2-ylcarbamate. Fosamprenavir calcium c)(S)-tetrahydrofuran-3-yl (2S,3R)-4-(4-amino-N-isobutylphenyl sulfonamido)-3-hydroxy-1phenylbutan-2-yl carbamate. Fosaprepitant dimeglumine a)5-[[(2R,3S)-2-[(IR)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]3-(4-fluorophenyl)-4morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Fosaprepitant dimeglumine b)Benzyl hydrogen 3-(((2R,3S)-2((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(4fluorophenyl)-4-morpholino)methyl)-5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-ylphosphonate. a) [(2-Methyl-1-(1-oxopropoxy)propoxy)(4-phenylbutyl)phosphinyl]acetic acid. 595 596 597 598 599 Fosinopril Sodium Fosinopril Sodium 600 Frovatriptan succinate 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 Frovatriptan succinate Fulvestrant Fulvestrant Fulvestrant Fulvestrant Fulvestrant Fulvestrant Furosemide Furosemide Furosemide Furosemide Fusidic acid Fusidic acid Fusidic acid Fusidic acid Fusidic acid Fusidic acid Fusidic acid Fusidic acid Fusidic acid Gabapentin Gabapentin b)[1[1[S*(R*),2-Alfa,4-beta]2Alfa,4-beta]-4-cyclohexyl-1-[4-cyclohexyl -1-[[[2-methyl-1-(1oxopropoxy)propoxy]-(4-phenylbutyl) phosphinyl] acetyl] -L-prolyl]-L-proline-sodium salt. a) (3S)-2,3,4,9-Tetrahydro-3-(methylamiano)-1H-carbazole-6-carboxamide, Succinate. (Sisomer-97.3%) b) (+)-3-Methyamino-1,2,3,4-Tetrahydro-6-carboxylic acid. ∆6,7-Fulvestrant 7b-fulvestrant Fulvestrant Sulfone Fulvestrant Extended Fulvestrant Dimer 6- keto-fulvestrant Furosemide Impurity-A Furosemide Impurity-B Furosemide Impurity-C Furosemide Impurity-D Fusidic acid Imp A Fusidic acid Imp I Fusidic acid Imp C Fusidic acid Imp D Fusidic acid Imp J Fusidic acid Imp K Fusidic acid Imp L Fusidic acid Imp M Fusidic acid Imp O a) Cyclohexane-1,1-diacetic acid. b) 2-]1-(Carbamoyl methyl)cyclohexyl]acetic acid. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 Gabapentin Galantamine Galantamine Galantamine Ganciclovir Ganciclovir GATIFLOXACIN GATIFLOXACIN GATIFLOXACIN GATIFLOXACIN GATIFLOXACIN GATIFLOXACIN GATIFLOXACIN GATIFLOXACIN Gatifloxacine Gatifloxacine Gatifloxacine Gatifloxacine Gefitinib Gefitinib Gefitinib Gemcitabine Gemcitabine Glibenclamide Gliclazide Glimepiride 649 a)N-(3,5-dichloro-4-fluoro phenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine. b)3-chloro-4-fluoro aniline c)7-Methoxy-6-(3-morpholinopropoxy)-3,4-di hydro-4-quinazolinone a) 2’-Deoxy-2’;2’-difluorocytidine.(α-Anomer) b) 4-Aminopyrimidin-2(1H)-one.(Cytocine). Impurity -C as per EP of Glibenclamide API Gliclazide Impurity-A a) Methyl[[4-[2-[[(3-ethyl-4-methyl-2-oxo-2,3 dihydro-1H-Pyrrole-1yl)carbonyl]amino]ethyl]phenyl]sulphonyl]carbamate. Glimepiride b) 3-Ethyl-4-mehyl-2-oxo-N-[2-(4-sulphamoylphenyl)ethyl]-2,3-dihydro-1H-Pyrrole-1carboxamide. Glimepiride c) 1-[[4-[2-[[(3-ethyl-4-methyl-2-oxo-2,3-dihydro-1H-Pyrrol-1yl)carbonyl]amino]ethyl]phenyl]sulphonyl]3-(cis-4-methylcyclohexyl)urea. Glimepiride Related Compound A Glimepiride Related Compound B Glimepiride Related Compound C 650 651 652 653 654 Gabapentin related Compound ‘A’ USP............ Norgalantamine [USP:N-Desmethylgalantamine]---O-Desmethylgalantamine Galantamine N-oxide [USP:6β-Hexahydrogalantamine]---a) 2-Amino -1H-purin-6(9H)-one. b) 2-Amino-7-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-1,7-dihydro-6H-Purin-6-one. 8 HYDROXY GATIFLOXACIN DIFLUROHYDROXY GAIFLOXACIN DIFLUROMETHOXY GAIFLOXACIN DESMETHYL GATIFLOXACIN DESPROPYLENE GATIFLOXACIN IMPURITY (RS)-2AMINO-4PHENYL BUTANOIC ACID RSS ISOMER LISINO IMP CYCLOHEXYL ANALOG LISINO IMP 8 hydroxy gatifloxacin Difluorohydroxy gatifloxacin Difluoromethoxy gatifloxacin Desmethyl gatifloxacin Glimepiride Glimepiride Glimepiride "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 685 686 687 688 Glimepiride Glimepride Glimepride GOD Guaifenesin Guaifenesin Guaifenesin Guaifenesin Hydralazine hydrochloride Hydralazine hydrochloride Hydralazine hydrochloride Hydrochlorothiazide Hydrochlorothiazide Ibuprofen Ibuprofen Ibuprofen Imatinib mesylate Imatinib mesylate Imatinib mesylate Impurities Impurities Impurities Impurities Impurities Impurities Irbesartan Irbesartan Irbesartan Irbesartan Irbesartan Irbesartan Irbesartan Irbesartan Irbesartan Glimepiride Related Compound D Glimepride Related Compound B Glimepride Related Compound C GOD2-Amino-5-methyl thiophene-3-carbonitrile GUAIACOL (liquid) Guaifenesin Impurity B Guaifenesin Impurity C (liquid) Guaifenesin Impurity D (Solid) a) 1-Phthalazinone. b) 2-Formylbenzoic acid. c) 1-Clorophthalazine. 5-chlorohydrochlorothiazide Hydrochlorothiazide dimer Ibuprofen Imp D Ibuprofen Imp E Ibuprofen Propyl Analogue a) N-(2-methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine -amine. b) N-[4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]-amino]phenyl]4-methylbenzamide methanusulfonate. c) Benzoic acid,4-[(4-methyl -1-piperazinyl)methyl]dihydrochlorde. Impurity B Impurity C Impurity D Impurity E Impurity F Impurity G 1-Amino-1-cyanocyclopentane Hydrochloride 2-Butyl-1,3-diazaspiro[4.4]non-1-en-4-one Hydrochlorid N-Triphenylmethyl Irbesartan Irbesartan Impurity A Irbesartan Impurity B Irbesartan Impurity C Irbesartan Impurity D Irbesartan Irbesartan related compounA "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Irbisartan 689 690 691 692 693 694 a) 1-pentanoylamino-cyclopentanecarboxylic acid [2’-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]amide. (USPRCA) b) 4-Bromomethyl-2’-cyanobiphenyl. Irbisartan Irbisartan c)2-propyl-3-[[2’(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4,4]non-1-en-4-one. d) 1-[(2’cyanobiphenyl-4-yl)mehyl]-2-N-butyl-4-spirocyclopentane-2-imidazolin-5-one. e)N-(triphenylmeyhyl)-5-[4’-(bromomethyl biphenyl)-2-yl]tetrazole. f)2-N-butyl-4-spirocyclopentane-2-imidazolin-5-one hydrochloride. Irbisartan Irbisartan Irbisartan Irbisartan g)2-butyl-3-[2’-(1-triphenylmethyl-1H-tetrazol-5-yl)biphenyl-4-yl methyl]-1,3-diazaspiro[4,4]non1-en-4-one. 695 Irbisartan 696 697 h)2-propyl-3-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl-4-yl methyl]-1,3-diazaspiro[4,4]non-1-en-4one. ( i)1-[(2’-cyanobiphenyl-4-yl)methyl]-2-n-butyl-4-spirocyclopentane-2-imidazolin-5-one. Irbisartan Irbisartan j)3-((2’(1-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)mrthyl)-1H-tetrazol-5-yl) biphenyl -4-yl)methyl)-2butyl-1,3-diazaspiro[4.4]non-1-en-4-one. 698 Irbisartan k) b)3-((2’(2-((2’-(1H-tetrazol-5-yl)biphenyl-4-yl)mrthyl)-2H-tetrazol-5-yl) biphenyl -4-yl)methyl)2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one. Ironotecan hydrochloride trihydrate a)(4S)-4,11-Diethyl-4,9-dihydroxy-1H-pyrano[3’,4’:6,7] indolizino [1,2-b]quinoline-3,14(4H,12H)dione. 699 700 701 702 703 704 705 ISOPROPYL PARA TOLUENE SULFONATE Isopropyl Isopropyl Isopropyl Isopropyl Itraconazole 706 a) 4-[4-[4-[4-[[Cis-2-(2,4-dichlorophenyl)-2-(1H-1, 2,4-triazol-1-ylmethyl)-1,3-dioxolan-4yl]methoxy]phenyl]piperazin-1yl]phenyl]-2-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1ylmehyl)-1,3-dioxolan-4-yl]methyl]-2,4-dihydro3H-1,2,4-triazol-3-one. Itraconazole b) 4-[4-[4-[4-Methoxyphenyl)piperazin-1-yl]phenyl]-2-[(IRS)-1-methylpropyl]-2,4-dihydro-3H1,2,4-triazol-3-one. Itraconazole c) 2-Butyl-4-[4-[4-[4-[[Cis-2-(2,4-dichlorophenyl)-2-(1H-1, 2,4-triazol-1-ylmethyl)-1,3-dioxolan-4yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-,4-dihydro-3H-1,2,4-triazol-3-one. 707 708 Itraconazole 709 ISOPROPYL PARA TOLUENE SULFONATE Isopropyl hexadecanoate Alfa cyclodextrin Gamma cyclodextrin Beta cyclodextrin d) 4-[4-[4-[4-[[Trans-2-(2,4-dichlorophenyl)-2-(1H-1, 2,4-triazol-1-ylmethyl)-1,3-dioxolan-4yl]mehyoxy]phenyl]piperazin-1yl]phenyl]-2-[(IRS)-methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3one. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Itraconazole e) 4-[4-[4-[4-[[Cis-2-(2,4-dichlorophenyl)-2-(1H-1, 2,4-triazol-1-ylmethyl)-1,3-dioxolan-4yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1-mehtylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one. Itraconazole f) 4-[4-[4-[4-[[Cis-2-(2,4-dichlorophenyl)-2-(1H-1, 2,4-triazol-1-ylmehyl)-1,3-dioxolan-4yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1-propyl)-2-,4-dihydro-3H-1,2,4-triazol-3-one. a) (1S)-4, 5-Dimethoxy-1-[(mehtylamino) methyl] benzocylobutane hdydrochloride. 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 Ivabradine hydrochloride Ivabradine hydrochloride b) 3-(3-(((4, 5-Dimethoxy)-1, 2-dihydrocyclobutabenzen-1-yl) methyl)(methylamino)propyl)-7,8dimethoxy-1H-benzo[d]azepin-2(3H)-One,oxalate salt. Ketoprofen Imp A Ketoprofen Imp B Ketoprofen Imp C Ketoprofen Imp D Ketoprofen Imp E Ketoprofen Imp F Ketoprofen Imp G Ketorolac Related Compound-A: (2R)-2-Amino-N-benzyl-3-methoxy propanamide a) (R)-2-Amino-N-benzyl-3-methoxy propanamide. b) (2S)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide. (LCMRC01) Ketoprofen Ketoprofen Ketoprofen Ketoprofen Ketoprofen Ketoprofen Ketoprofen Ketorolac Lacosamide Lacosamide Lacosamide Lamivudine (a) 4-Amino-1-[(2R,3S,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pymidin-2(1H)-ONE SOxide. 725 Lamivudine 726 727 728 729 730 731 732 (b) 4-Amino-1-[(2R,3S,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pymidin-2(1H)-ONE SOxide. a) 2,3-Dichloro benzoic acid. b) N-[5-Amino-6-(2,3-Dichlorophenyl)-1,2,4-triazin-3-yl]-2,3 dichlorobenzamide.. a)2-(Chloromethyl-3-methyl-4-(2,2,2-trifluoethoxy)-pyridine. b) 1H-Benzimidazole-2-thiol. Lamotrigine benzoic acid Lamotrigine benzoic acid Lansoprazole Lansoprazole Lansoprazole c) (2[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfonyl]-1Hbenizimidazole).(lansoprazole sulfone)(USPRCA) d)2[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]thio]-1H-benzimidazole.(USPRCC) Lansoprazole Lansoprazole e) 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1Hbenizimidazole).(lansoprazoleN-Oxide)(EP-A) 733 Lapatinib ditosylate monohydrate a) N-[3-Chloro-4-[(3-fluorophenyl)methoxy]pehnyl]-6-[5-[[[-2(methylsulphonyl)ethyl]imino]methyl]-2-furanyl]-4-quinazolinamine. Lapatinib ditosylate monohydrate b) 5-[4-[3-chloro-4-[(3-fluorobenzyloxy)aniline]-6-quinazolinyl]furan-2-carbaldehyde,4-methyl benzenesulphonate. 734 735 "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Lapatinib ditosylate monohydrate 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 757 758 759 Leflunomide Lenalidomide Lercanidipine hydrochloride Lercanidipine hydrochloride Letrozole Levetiracetam Levetiracetam Levetiracetam Levetiracetam Levetiracetam Levetiracetam Levetiracetam Levetiracetam Levetiracetam Levetiracetam Levoceitrizine Levodopa Levofloxacin Levofloxacin Levofloxacin Levofloxacin Levofloxacin Levofloxacin Levofloxcin hemihydrate 760 Valacyclovir related compound C ((2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl N-methyl-L-valinate hydrochloride))Levoceitrizine impurity 1. (Levodopa Impurity A)------- [CAS 27244-64-0] Decarboxy Levofloxacin Diamine derivative Levofloxacin N-Oxide 9-Desfluoro Levofloxacin Dextrofloxacin N-DESMETHYL LEVOFLOXACIN a) (S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-Pyrido[1,2,3-de][1,4]benzoxazine-6carboxylic acid. Levofloxcin hemihydrate b) (S)-9-fluoro-3-mehyl-10-(piperazine-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3de][1,4]benzoxazine-6-carboxylic acid.(Des.Methyl Levoflocacin.) Levofloxcin hemihydrate c)(+)- (R)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]1,4-benzoxazine-6-carboxylic acid. Levofloxcin hemihydrate d) 3-mehtyl-10-(4-mehtylpiperazin-1-yl]-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid. 761 762 763 c) N-(3-chloro-4-(3-fluorobenzyloxy)phenyl)-6-(5-((((5-(4-(3-chloro-4-(3fluorobenzyloxy)phenylamino)quinazolin-6-yl)furan-2-yl)mehtyl)(2(methylsulfonyl)ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine. Leflunomide Impurity D a)N-(2-(2,6-Dioxopiperdin-3-yl)-1-oxoisoindolin-4-yl)formamide.(LNDRC01) a) 2,6-Dimethyl-5-methyoxy carbonyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3-carboxylic acid. b) 1-[(3,3-Diphenylpropyl)methylamino]-2-methyl-2-propanol. a) 4,4-(1H-1,3,4-Triazol-1-ylmethylene)dibenzonitrile. a) (S)-N-(1-Amino-oxobutan-2-yl)-4-chlorobutanamide.(USPRCA) b) (S)-2-Amino-butanamide hydrochloride.(USPRCB) c) (S)-2-(2-Oxopyrrolidin-1-yl)butanoic acid. d) 2-Hydroxy pyridine. a)(αS)- α-Ethyl-2-oxo-1-pyrrolidine acetic acid. b)( αR)- α-Ethyl-2-oxo-1-pyrrolidine acetamide. c) (R)-(+)- α-Methyl benzylamine. Levetiracetam acid impurity Levetiracetam R-enantiomer impurity "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Levofloxcin hemihydrate 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787 788 789 790 791 792 793 Levosimendan Levosimendan Levothyroxine Lisinopril Lisinopril Lisinopril Lisinopril Lisinopril Locosamide Loperamide Loperamide Loperamide Loperamide Loperamide Loperamide Loperamide Loperamide Lopinavir Lopinavir Lopinavir Loratadine Loratadine Loratadine Loratadine Loratadine Loratadine Loratadine Loratadine Loratadine e) 9-Fluoro-2, 3-dihydro-3-methyl-10-(4-ethylpiperazinal-1-yl)-7-oxo-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid. a) (R)-6-(4-Aminophenyl)-4,5-dihydro-5-methylpyridazin-3(2H)-one. b) [[4-(4S)-1, 4, 5, 6-Tetrahydro-4-methyl-6-oxo-3-pyridazinyl] phenyl] hydrazono] propanedinitrile. Levothyroxine N-Methylamide a) Trifluoro acetyl L-lysine. b) (S)-1-Carboxy-3-phenylpropyl-L-lysine. c) 4-Methyl benzene sulphonic acid. d) (2S)-1-[(2S)-6-amino-2-[[(IR)-1-carboxy-3-phenylpropyl]amino]hexanoyl]pyrrolidine-2carboxylic acid. e) (R,S)-2-Amino-4-phenylbutanoic acid. Desmethyl Locosamide Loperamide impurity.....A Loperamide impurity.....B Loperamide impurity.....C Loperamide impurity.....D Loperamide impurity.....E Loperamide impurity.....F Loperamide impurity.....G Loperamide impurity.....H a) (2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino-3-hydroxy-5-trifluorormethyl carbonylamino-1,6-diphenylhexane. b) (2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino-3-hydroxy-5-amino 1,6-diphenyl hexane. c) N-[1-Benzyl-4-[2-(2,6-dimethyl-phenoxy)-acetylamino]-5-pehnyl-pent-3-enylidene]-3-methylbut-1-enimidic acid. Loratadine USP related compound C Loratadine USP related compound A Loratadine USP related compound B Loratadine N Oxide a) Impurity B, USP related compound C b) Impurity D, USP related compound A c) Impurity G, USP related compound B d) 4,8-chloro-5,6-dihydro- 11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11-one e) Loratadine-N-oxide "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 Loratadine Loratadine Lornoxicam Lornoxicam Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan Losartan potassium Losartan potassium Loratadine related compound A Loratadine related compound B a) 2-Amino pyridine. b) 6-Chloro-4-hydroxy-2-methoxycarbonyl-2H-Thieno[2,3-e]-1,2-thiazine-1,1--dioxide. Losartan Impurity D Losartan Impurity G Losartan Impurity J Losartan Impurity K Losartan Acid a)O-Acetyl Losartan b)Benzyl N-[(2’-(Trityltetrazol-5-yl-1,1’-biphenyl-4-yl]-methyl-2-amino-3-methylbutanoate c)N-(4-Bromobenzyl)-2-Butyl-4-chloro-1H-imidazole-5-Carboxylic Acid d)5-[4-(Dibromomethyl)[1, 1-biphenyl]-2-yl]-2-(Triphenylmethyl)-2H-tetrazole e)5-[4’-Bromomethyl-(1, 1’-biphenyl)-2-yl]-2-triphenylmethyltetrazole f)Tert-Butyl 4-Methyl-2-biphenylcarboxylate g)N, O-Ditrityl Losartan h)Losartan Carboxylic Acid i)5-(2-Fluorophenyl)-1H-tetrazole Hydrochloride j)5-[4’-Hydroxymethyl-(1,1’-biphenyl)-2-yl]-2-triphenylmethyltetrazole k)Losartan Carboxaldehyde l)Losartan Carboxylic Acid m)Losartan Isomer Impurity, Potassium Salt n)Losartan Trityl Ether o)4-Methyl-2-biphenylcarbonyl Chloride p)5-Phenyl-2- trityltetrazole q)2-[(1H-Tetrazol-5-yl)biphenyl-4-yl]methanol r)N-Trityl-5-(2-fluorophenyl)-1H-tetrazole s)N-Trityl Losartan t)N-Trityl Losartan Carboxaldehyde u)N-Trityl Losartan Carboxylic Acid v)2-(2-Trityl-2H-tetrazol-5-yl) phenylboronic Acid a) 4’-[(2-Butyl-4-chloro-5-(hydroxymethyl)-1H-Imidazol-1-yl)methyl]-[1,1’biphenyl]-2-carbonitrile. b) 4’-[(2-butyl-4-chloro-5-formyl-1H-imidazol-1-yl)methyl]-[1,1’-biphenyl]-2-carbonitrile. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Losartan potassium 827 828 829 830 831 832 833 834 Losartan Losartan Losartan Losartan Losartan Lovastatin Lovastatin Lurasidone hydrochloride 835 Lurasidone hydrochloride 836 837 838 839 840 841 842 843 844 845 846 Lymecycline Lymecycline Lymecycline Lymecycline Mamentine Mamentine Mamentine Maraviroc Maraviroc Maraviroc Maraviroc 847 Maraviroc 848 849 850 851 852 853 854 855 Meclizine Meclizine O-chloroisomer Mefenamic acid Mefenamic acid Mefenamic acid Meloxicam Meloxicam c) 2-Butyl-4-chloro-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]-methyl-1H-imidazole-5-carboxylic acid. Losartan Impurity-L (1H) Losartan Impurity-M (2H) Losartan related compound A Losartan related compound B Losartan IMP------c Lovastatin Epilovastatin (Impurity-F&E mix---) a) (3As,4S,7R,7Ar)-2-{(1R,2R)-2[4-(1,2-Benzisothiazol-3-yl)piperazin-1-yl Methyl] cyclohexylmethyl} hexahydro-4, 7-methano-2H-isoindole-1,3-dione hydrochloride. b) (3aR,7aR)-4’-(Benzo[d]isothiazol-3-yl)octahydrospiro[isoindole-2,1’-Piperazin]-1’-ium methane sulfonate. Lymecycline Impurity-A Lymecycline Impurity-C Lymecycline Impurity-D Lymecycline Impurity-G 1,3-Dimethyl Adamantane 3-Methyl adamantamine 1-Chloro-3,5 dimethyl Adamantane a) 4,4-Difluoro-N-[(1R)-3-[(3exo)-3-[3-methyl-5-(1-methylethyl)-4H-1,2,4-triazol-4-yl]-8azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl]-cyclohexanecarboxamide. b) Tert-butyl(1S)-3-[3-(Isopropyl-5-methyl-4H-1,2,4-triazol-4-yl]-exo-8Azabicyclo [3.2.1]oct-8-yl)-1-phenylpropylacarbamate. c) 4,4-Difluoro-N-[(1S)-3-[(3-endo)-3-[3-mehtyl-5-(1-methylethyl)-4H-1,2,4-triazol-4-yl]-8azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl]-cycloexanecarboxamide d) N-((S)-3-((1R, 3R, 5S)-3-(3, 5-diisopropyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1.]octan-8yl)-1-phenylpropyl)-4,4 difluorocyclohexanecarboxamide. 1,4-bis(3-methylbenzyl)piperazine, Meclizine O-chloroisomer Mefenamic acid Impurity –B Mefenamic acid Impurity –C Mefenamic acid Impurity –D Meloxicam impurity A Meloxicam impurity B "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 856 857 858 859 860 861 862 863 864 865 866 867 868 869 870 871 872 873 874 875 876 877 878 879 880 881 882 883 884 885 886 887 888 889 890 Melphalan Memantine MEMANTINE MEMANTINE MEMANTINE Mesalamine Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : a)Ethyl ester,4-[Bis(2-chloroethyl)amino]-L-Phenylalanine. a)1-acetamido-3,5-dimethyl adamantane. MEMANTINE RELATED COMPOUND-C MEMANTINE RELATED COMPOUND-D MEMANTINE RELATED COMPOUND-E 2-hydroxy-5(2-methyl-4-oxopentan-2-ylamino) Dehydro Nifidipine Trimbutine (N-desmethyl) Hydroxy Norgestrel Hydroxy Mifipristone N-desmethyl Ivabradine O-desmethyl Doneprizil N-desmehyl Miritazepine N-desmethyl Rizatriptan N-desmethyl Asenapine Aposcopolamine Budesonide Impurity-L Atorvastatin-D5 5-hydroxy propafenone Dehydro Lercandipine Bumetadine (1 &2) 5-hydroxy propafenone-D5 P-Hydroxy Atorvastatin P-Hydroxy Atorvastatin-D5 o-Hydroxy Atorvastatin o-Hydroxy Atorvastatin-D5 Atorvastatin-D5 Difluoro Atorvastatin 5-Hydroxy Propiophenone 4-Hydroxy Propiophenone 5-Hydroxy Propiophenone-D5 4-Hydroxy Propiophenone-D5 4-Hydroxy Propanolol HCl Lercandipine (3) Bumetanide (2) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 891 892 893 894 895 896 897 898 899 900 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Doxorubicinol Doxorubicinone Diclofenac Impurity-D Budesonide (Imp-D and G) N-Demethyl Rizatriptan Prothionamide Sulfoxide Rizatriptan-n-Oxide Oseltamavir Carboxylic acid Carbamazepine-10,11-Hydroxy N-desmethyl Ivabradine N-desmethyl Loperamide N-Desemthyl Mifepristone Hydroxy Mifipristone O-desmthyl Lacosamide 17-alpha-deacetyl Norgestral 4-Methyl aminoantipyrine Curcumin Sulphate 3-hydroxy methyl pyridonium salt Amoxicilline Diketo pyperizine 4-oxo Isotritionine Prasugrel Metabolite Tetrahydro Curcumin Octahydro Curcumin 6-Beta Hydroxy Norgestral Dehydro Lacidipine Docosohexanoic acid ethyl ester Celecoxib Carboxylic acid Carbamazepine 10,11-dihydro epoxy L-Carglutamic acid "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Metabolites In Stock : 920 O-Desmethyl Mebeverine Metabolites In Stock : 921 Mebeverinol Metabolites In Stock : 922 923 924 925 926 927 928 929 930 931 Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : Metabolites In Stock : 932 Doxorubicinolone Hydroxy Celecoxib N-desmethyl Scopolamine Endoxefin Thyroxine Impurity Pyridoxamine Phosphate Salt Budesonide Impurity A Budesonide Impurity K Lansoprazole Sulphone 4-oxo Retinoic acid Desfuryl Ceftiofur Metabolites In Stock : 933 N-Amine Metabolites In Stock : 934 935 936 937 938 939 940 941 942 943 Metformin Metformin Metformin Metformin Hydroxy Solifinacin-N-Oxide Hydroxy Solifinacin a) 3-(3, 5-Dimethylphenoxy)-2-hydroxy-propylamine hydrochloride. b) Ethyl 3-(3, 5-Dimethylphenoxy)-2-hydroxypropyl carbonate. c) 3, 5-Dimethylphenol. Metformin Related Compound B Metformin Related Compound C Metformin Related Compound A (1-Cyanoguanidine) Metformin Imp D Metformin R = N(CH3)2: N,N-dimethyl-1,3,5-triazine-2,4,6-triamine Metabolites In Stock : Metaxalone Metaxalone Metaxalone "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 944 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 971 972 973 974 975 Metformin Metformin Metformin Metoprolol Metoprolol Metoprolol Metoprolol Metronidazole Metronidazole Metronidazole Metronidazole Mifepristone Mifepristone Milnacipran hydrochloride Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast Montelukast sodium R = NH2: 1,3,5-triazine-2,4,6-triamine (melamine) 1-methylbiguanide Metformin imp D Metoprolol Impurity A Metoprolol Impurity B Metoprolol Impurity C Metoprolol Impurity D 2-Methyl-5-nitroimidazole (Metronidazole impurity)- USP, BP 2-methyl-imidazole 2-(2-Methyl-4-nitro-1H-imidazol-l-yl)ethanol 2-[(2-Methyl-5-nitro-1H-imidazol-l-yl)eththoxy]ethanol Hydroxy Mifepristone N-desmethyl Mifepristone a) 2-[(1, 3-Dioxo-2, 3-dihydro-1H-isoindol-2-yl) methyl] N, N-diehtyl-1-phenylcycloprapane-1carboxamide. a) Montelukast Methyl Ester b) Montelukast Cyclopropaneacetonitrile c) Montelukast (3R)- Hydroxy Propanol d) Montelukast (3RS)- Hydroxy Propanol e) Montelukast Cis-Isomer f) Montelukast EP Impurity I g) Montelukast Methylketone h) Montelukast Methyl styrene i) Montelukast Michael Adducts (mixture of Diastereomers) j) Montelukast S-Enantiomer k) Montelukast Sulfoxide l) Montelukast IMP H m) Montelukast Related Comp. 2 2-(1-((((R)-1-(3-(2-(7-chloroquinolin-2-yl) ethyl) phenyl)-3-(2-2hydroxypropan-2-yl) phenyl) propyl) sulfanyl) methyl) cyclopropyl) acetic acid n) Montelukast Related Comp. 3 (1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl) ethenyl] phenyl]-3-[2-(1hydroxy-1-methylethyl) phenyl] propyl] thio] methyl)cyclopropaneacetamide a) 2-(1-((((R) -1-(3-(2-(7-Chloroquinolin-2-yl)ethyl)phenyl)-3-(2-(2-hydroxypropan-2yl)phenyl)propyl)Sulfanyl)methyl)cyclopropyl)acetic acid. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Montelukast sodium b) 1-[[[(IR)-1-[3-[(IE)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1methylethyl)phenyl]propyl]thio]methyl]cyclopropane acetamide. Montelukast sodium c) [1-[[[1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl)phenyl)-3-(2-(2-hydroxpropan-2yl)phenyl]propyl]sulfinyl]methyl]cyclopropyl]acetic acid.(Sulfoxide impurity) Montelukast sodium d) 1-[[[(IRS)-1-[3-[(IE)-2-(7-Chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(prop-1-en-2yl)phenyl])propyl]sulfanyl]methyl]cyclopropyl]acetic acid. 976 977 978 Montelukast sodium 979 e) 2-[2-[3(S)-[3-[2-(7-Chloro-2-quinolinyl)-ethenyl][phenyl]-3-hydroxypropyl]phenyl]-2-propyanol. Montelukast sodium 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 998 999 1000 1001 1002 1003 Montelukast Montelukast Montelukast Mosapride Mosapride Mosapride Mosapride Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin Moxifloxacin hydrochloride f) 1-[[[(IR)-1-[3-[(IZ)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1methylethyl)phenyl]propyl]thio]methyl]cyclopropane acetic acid Montelukast Sulphoxide impurity Montelukast Styrene impurity Montelukast Imp G Mosapride N-Oxide Des-4-fluorobenzyl Mosapride 2-Aminomethyl-4-(4-fluorobenzyl)morpholine Mosapride Citric Amide Disodium Salt Moxifloxacin impurity D Moxifloxacin impurity E( EP) 8-hydroxy impurity Moxifloxacin Related Compound A Moxifloxacin Related Compound B Impurity A Impurity B Impurity C Impurity D Impurity E N-Methyl R,R-isomer a)Moxifloxacin impurity A b)Moxifloxacin impurity B c)Moxifloxacin impurity C d)Moxifloxacin impurity D a) 1-Cyclopropyl-6,8-difluoro-7-[(4aS, 7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4dihydroquinoline-3-carboxylic acid hydrochloride.(EP-A) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Moxifloxacin hydrochloride b) 1-Cyclopropyl-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo1,4-dihydroquinoline-3-carboxylic acid.(EP-B) Moxifloxacin hydrochloride c) 1-cyclopropyl-8-ethoxy-6-fluoro-7-[(4aS,7aS)-octahydro-6H-Pyrrolo[3,4-b]pyridi-6-yl]-4-oxo1,4-dihydroquinoline-3-carboxylic acid.(EP-C) Moxifloxacin hydrochloride d) 1-Cyclopropyl -6-fluoro-8-methoxy-7-[(4aR,7aR)-octahydro-6H-pyrrolo[3,4b]pyridin-6-yl]-4oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. e) 1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017 Moxifloxacin hydrochloride Moxifloxacin hydrochloride f) 1-Cyclopropyl-6-fluoro-8-hydroxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4oxo-1,4-dihedroquinoline-3-carboxylic acid.(EP-E) a)4,6-Dichloro-N-(imidazolidin-2-ylidene)-2-methylpyrimidin-5-amine. Moxonidine: Naratriptan hydrochloride a) 2-[3-(1-Methyl-1,2,3,6-tetrahydropyridine-4-yl)1H-indole-5yl]-ethane sulfonic acid methylamide. (USPRCB) b) 3-(1-Methyl piperidin-4-yl)-1H-Indole. (USPRCA) a) N-(trans-4-ethylcyclohexylcarbonyl)-D-phenylalanine. b) N-(trans-4-Isopropylcyclohexylcarbonyl)-D-phenylalanine-D-phenylalanine c) N-(trans-4-Isopropylcyclohexylcarbonyl)-D-phenylalanine-ethyester.() d) Phenylalanine. e) Trans-4-isopropylcyclohexylcorboxylic acid.(USPRCA) f) N-(trans-4-isopropylcyclohexylcarbonyl)-L-phenylalanine. Naratriptan hydrochloride Nateglinide Nateglinide Nateglinide Nateglinide Nateglinide Nateglinide Nateglinide 1018 g) N-(cis-4-isopropylcyclohexylcarbonyl)-D-Phenylalanine.(USPRCC)() (Cis-66%,Trans 29%) Nebivolol hydrochloride a) [2S*[IR*,5S*(S*)]]-alfa,alfa’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran2-methanol. Nebivolol hydrochloride b) [2S*[IR*,5R*(S*)]]-alfa,alfa’-[Iminobis(Methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran2-methanol]. c) (±)-[1S*(S*)]6-Flouro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran. NEBIVOLOL RELATED COMPOUND A NEBIVOLOL RELATED COMPOUND B a) 3-Hydroxy-2-methyl benzoic acid. b) 3-Acetyloxy-2-methyl benzoic acid. 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 Nebivolol hydrochloride NEBIVOLOL NEBIVOLOL Nelfina vir mesylate Nelfina vir mesylate Nelfina vir mesylate Nelfina vir mesylate N-ETHOXYCARBONYL-7-ADCA Nevirapine c) (3S,4AS,8AS)-N-(1,1-Dimethylethyl)decahydro-2-[(2R,3R)-2-hydroxy-3-amino-4(phenylthio)butyl]-3-isoquinolinecarboxamide. d) Benzoic acid. N-ETHOXYCARBONYL-7-ADCA a) N-(2-Chloro-4-methyl-3-pyridyl)-2-(cyclopropylamino)-3-pyridinecarboxamide. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1030 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040 1041 1042 1043 1044 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 1058 1059 1060 1061 1062 Nevirapine Nevirapine Nevirapine Nifidipine Nilotinib hydrochloride Nilotinib hydrochloride Nimesulide Nimesulide Nimesulide Nimesulide Nimesulide Nimesulide Norgestrel Nortriptyline Hcl Impurities Nortriptyline Hcl Impurities Nortriptyline Hcl Impurities Nortriptyline Hcl Impurities Ofloxacin Ofloxacin Olanzapine Olanzapine Olanzapine Olanzapine Olanzapine Olanzapine Olanzapine Olanzapine Olanzapine Olanzapine Olefinic Olefinic Olmesartan medoxomil Olmesartan medoxomil b) [5,11-Dihydro-6H-11-ethyl-4-methyl-dipyrido[3,2-b;2’,3’-e][1,4]diazepin-6-one].(USPRCA) c) 2-((2’-Cyclopropylamino)-3’-pyridyl)-7-methyloxazolo[5,4-B]-pyridine. d) 11-Propyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b;2’3’-e][1,4]diazepin-6-one. Dehydro Nifidipine a) 3-(4-methyl-1H-Imidazole-1-yl)-5-(trifluoro methyl)benzenamine. b) 4-methyl-3-(4-(pyridine-3-yl)pyrimidin-2-yl amino)benzoic acid. Nimesulide Impurity D (Ph. Eur). Nimesulide Impurity A Nimesulide Impurity B Nimesulide Impurity C Nimesulide Impurity E Nimesulide Impurity F 17-deacetyl Norgestrel Impurity A EP grade Impurity B EP grade Impurity D EP grade Impurity F EP grade Ofloxacin impurity F Ofloxacin impurity B a) 4-Amino-2-methyl-10H-thieno-[2,3-b][1,5]benzodiazapine. b) 2-Methyl-4-(1-piperazinyl)-10H-thieno-[2,3-b][1,5]benzodiazepine. c) 2-(1,2-phenylenediamino)-5-methyl-thiophene-3-carbonitrile. d) 2-Methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-4-one. e) 2-Methyl-4-[4-ethyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine.()( f) 2-(2-Nitroaniline)-5-methyl-thiophene-3-carbonitrile. g) 2-Amino-5-methyl-thiophene-3-carbonitrile. h)1-Flouro-2-nitro benzene. Olanzapine Related Compound A 1-(5'methylthiophen-2-yl)-1,3-dihydrobenzoimaidazole-2-one Olefinic impurity N-alkyl impurity a) (5-methyl-2-oxo-1,3-dioxol-4-yl)mehtyl-4-(2-hydroxy-propan-2-yl)-2-propyl-1-[[2’-(1triphenylmethyl-1H-tetrazole-5-yl)biphenyl-4-yl]methyl]-1H-imidazole-5-carboxylate.(EP-D) b) Tri phenyl methanol. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Olmesartan medoxomil 1063 Olmesartan medoxomil 1064 Olmesartan medoxomil 1065 1066 1067 1068 1069 1070 1071 1072 1073 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 Olmesartan Olmesartan Olmesartan Olmesartan Olmesartan Olmesartan Olopatadine Olopatadine Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole magnesium Omeprazole magnesium Omeprazole magnesium Omeprazole magnesium Omeprazole magnesium Omeprazole c) 4-(2-Hydroxypropan-2-yl)-2-propyl-1-[[2’-(1H-tetrazole-5-yl)-biphenyl-4-yl]methyl]-1HImidazole-5-carboxylic acid.(EP-A) d) 4-[1-Hydroxy-1-methylethyl]-2-propyl-1-[[2’-[1(triphenylmethyl)-1H-Tetrazol-5-yl]1,1’biphenyl-4-yl-methyl]-1H-imidazole-5-carboxylicacid(5-methyl-2-oxo-1,3-dioxal-4-yl)methyl ester. e) 4-[1-Hydroxy-1-methylethyl]-2-propyl-1-[[2’-1H-tetrazole-5-yl]1,1’-biphenyl-4-yl-methyl]- 1HImidazole-5-carboxlylic acid. Olmesartan medoxomil related compound A Olmesartan medoxomil Trityl olmesartan (N-alkyl impurity ) Olmesartan Impurity-A, Olmesartan acid OLMESARTAN IMPURITY C α – Hydroxy Olopatadine OLopatadine E-Isomer a) Omeprazol Impurity A b) Omeprazol Impurity C c) Omeprazol Impurity D d) Omeprazol Impurity E e) Omeprazol Impurity F f) Omeprazol Impurity I g) 5-O-Desmethyl Omeprazole Sulfide h) Desmethyl Omeprazole Impurity i) 4-Hydroxy Omeprazole Sulfone j) 4-Acetyloxy Omeprazole k) 4-Acetyloxy Omeprazole Sulfone. l) 5-Benzyloxy Omeprazole a) 5-Methoxy-1H-benzimidazole-2-thiol.(EP-A) b) 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]thio]-1H-benzimidazole. (EP-C) c) 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]thio]-1Hbenzimidazole.(EPD) d) Pyridine,2-(chloromethyl)-3,5-dimethyl-4-methoxy hydrochloride. e) 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridine-2-yl)methyl]sulfonyl]-1H-benzimidazole 1’oxide.(EP-E) Omeprazole EP imp B(USP Desmethoxy omeprazole) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1092 1093 1094 1095 1096 1097 1098 1099 1100 1101 1102 1103 1104 1105 1106 1107 1108 1109 1110 1111 1112 1113 1114 1115 1116 1117 1118 1119 1120 1121 1122 1123 1124 1125 Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Omeprazole Ondansetron Oselamavir Oselamavir Oseltamivir Oseltamivir phosphate Oseltamivir phosphate Oseltamivir phosphate Oseltamivir phosphate Oseltamivir phosphate Oseltamivir phosphate Oseltamivir Oxcarbazipine Oxcarbazipine Oxcarbazipine Omeprazole EP impurity C 5-Methoxy-1-Hbenzimidazole2-thiol (Omeprazole imp-A) Omeprazole EP Imp-G Omeprazole EP Imp-F 5-Methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulphinyl-1-methyl benzimidazole 2-Chloromethyl-3,5dimethyl-4-methoxypyridine HCl (Omeprazole EP imp-XI ) Omeprazole EP imp-H Omeprazole -4- Chloro Analog Omeprazole Sulphide Omeprazole chloro impurity OMEPRAZOLE IMPURITY-A Omeprazole IMPURITY-B Omeprazole IMPURITY-C Omeprazole IMPURITY-D Omeprazole IMPURITY-E Omeprazole IMPURITY-F Omeprazole IMPURITY-G Omeprazole IMPURITY-H Omeprazole IMPURITY-I 6-Methoxy-8-Fluoro Impurity Ondansetron Impurity (C) Oselamavir Acid ( Imp A) Oseltamavir Phenol ( Imp B) Oseltamivir carboxylic Acid a) (3R,4R,5S) Methyl4-Acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate. b) c) (3R,4R,5S) -4-Acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid e) 4-acetylamino-3-hydroxy benzoic acid ethyl ester. f) (3R,4R,5S)-4-(Acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylicacid g) Triphenyl phosphine oxide. h) Ethyl(3R,4R,5S)-4-(Acetylamino)-5-azido-3-(ethylpropoxy)-1-cyclohexene-1-carboxylate. (3R, 4R, 5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohex-ene-1-carboxylic acid 10,11,dioxo impurity ( 10-Hydroxy-10,11-dihydro-5H-dibenzoazepine-5-carboxamide) Oxcarbazepine metabolite ( 10-Hydroxy-10,11-dihydro-5H-dibenzoazepine-5-carboxamide Oxcarbazepine impurity A "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1126 1127 1128 Oxcarbazipine Oxybutynin Chloride Oxybutynin Chloride Paclitaxile 1129 Paclitaxile 1130 Oxcarbazepine impurity C Diphenyl analogue of Oxybutynin Chloride Ethyl propyl analogue of Oxybutynin Chloride a) (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzoyloxy)1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,6,9,11-tetrahydroxy-4a,8,13,13-tetramethyl7,11-methano-5H-cyclodeca(3,4)benz(1,2-b)oxet-5-one. b) 6,12b-Bis(acetyloxy)-12-(benzoyloxy)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro4,9,11-trihydroxy-4a,8,13,13-tetramehtyl-(2Ar,4S,4as,6R,9S,11S,12S,12aR,12bS)-rel-7,11methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5-one. Paclitaxile c) (2α,4α,5β,7β,10β,13α)-4-(Acetyloxy)-13-{[(2R,3S)-3-(benzoylamino)-2-hydroxy-3phenylpropanoyl]oxy}-1,7,10-trihydroxy-9-oxo-5,20-epoxytax-11-en-2-ylbenzoate. Paclitaxile d) (2α,4β,5β,7α,10β,13α)-4,10-Bis(acetyloxy)-13-{[(2R,3S)-3-(benzoylamino)-2-hydroxy-3phenylpropanoyl]oxy}-1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-2-ylbenzoate. 1131 1132 Paclitaxile 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142 1143 1144 1145 1146 Paliperidone Paliperidone Paliperidone Paliperidone Paliperidone Paliperidone Paliperidone Paliperidone Paliperidone Paliperidone Pantoic acid Pantoprazole sodium Pantoprazole sodium Pantoprazole sodium 1147 Pantoprazole sodium 1148 e) (2aS,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6-12b-Bis(acetyloxy)-12(benzyloxy)2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-11-hydroxy-4a,8,13,13-tetramethyl5-oxo-4-[[(2,2-dichloroethoxy)carbonyl]oxy]-7,11-methano-1H-cyclodeca[3,4]benz[1,2b]oxet-9yl ester,(αR,βS)-β-(benzoylamino)-α-hydroxy-benzenepropanoic acid. Paliperidone Keto Impurity Paliperidone N Oxide Impurity Paliperidone ETHMPPO impurity Paliperidone Related Compound A Paliperidone Related Compound B Paliperidone Related Compound C Paliperidone Related Compound D PALIPERIDONE DESCHLORO IMPURITY PALIPERIDONE PIPERADINE IMPURITY PALIPERIDONE N-OXIDE IMPURITY Pentanoic acid a) 5-(difluoromethoxy)-1H-benzimidazole-2-thiol. (EP-C) b) 2-(Chloromethyl)-3,4-dimethoxy-pyridine hydrochloride. ( c) 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulphonyl]-1H-Benzimidazole. (EPA) d) 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl]methyl]sulphanyl]-1H-benzimidazole. (EPB) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1149 1150 1151 1152 1153 Pantoprazole Sodium Pazopanib hydrochloride Pazopanib hydrochloride Pemetrexed disodium 2.5 hydrate Pemetrexed disodium 2.5 hydrate Pemetrexed disodium 2.5 hydrate 1154 Perindopril Erbumine 1155 1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 Perindopril Erbumine Pioglitazone hydrochloride Pioglitazone hydrochloride PIOGLITAZONE PIOGLITAZONE PIOGLITAZONE PIOGLITAZONE PIPERAZINE Pirfenidone Pirfenidone Piroxicam Piroxicam Piroxicam Piroxicam Piroxicam Pitavastatin calcium 1171 Pitavastatin calcium 1172 Impurity-A a) 5-amino-2-methyl benzene sulphonamide. b) N-(2-Chloropyrimidin-4-yl)N-2,3-trimethyl-2H-indazol-6-amine. a) N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-D-glutamic acid disodium salt. b) N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoic acid. c) N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzoyl]-L-glutamic acid dimetyl ester 4-toluene sulphonic acid salt. a)(2S, 3AS,7AS)-1-[(S)-N-[(S)-1-Carboxybutyl]alanyl]ocatahydro-1H-Indole-2-carboxylic acid.(EP-B) b) (2S,3aS, 7aS)-octahydro-1H-Indole-2-carboxylic acid.(EP-A) a) 5-[[4-2-(5-Ethyl-2-pyridyl)ethoxy]phenyl]methyl]-2-imino-thiazolidine-4-one. b) 5-{4-[2-(5-Ethyl-2-pyridyl)ethoxy]benzyl}-4-[4-[2-(5-ethyl-2-pyridyl)ethoxy]phenoxy]-2,5dihydro-1,3-thiazole-2-one. PIOGLITAZONE IMPURITY PGS-2 PIOGLITAZONE IMPURITY PIO-II Didehydroxypioglitazone n-Alkylpioglitazone N-ETHYL PIPERAZINE A) 2-Amino-5-mehtyl pyridine. B) 5-methyl pyridine-2(1H)-one. Piroxicam Impurity A (2-Amino pyridine) Piroxicam (EP), impurity B Piroxicam (EP), impurity D Piroxicam (EP), impurity G Piroxicam (EP), impurity J a) (3R,5S,E)-7-(2-Cyclopropyl-4-(4-fluoropehnyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid,calcum salt. b) (4R,6S)-6-((E)-2-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)vinyl)-4-hydroxytetrahydro2H-pyran-2-one. Pitavastatin calcium 1173 c)(S,E)-6-(-2-(2-cyclopropyl-4-(4-fiuorophenyl)quinolin-3-yl)vinyl)-5,6-dihydro-2H-pyran-2-one. Pitavastatin calcium 1174 d) (4R,6S)-6-((E)-2-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)vinyl)-4-hydroxytetrahydro2H-pyran-2-one. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Pitavastatin calcium 1175 1176 1177 1178 1179 1180 e) (3R,5S,E)-teri-butyl-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihroxyhept-6enoate A) (4-((1, 4, 8, 11-tetrazacyclotetradecan-1-yl) methyl) phenyl) methanol. Plerixafor Plerixafor B) N-(4-((1, 4, 8, 11-tetrazacyclotetradecan-1-yl) methyl) benzyl)-N, N-diethyethanaminium chloride . a) 10-propargyl-4-amino-10-deazaptrroic acid. b) 10-propargyl-10-deazaminopterin diethyl ester. c) L-Glutamic acid diethyl ester hydrochloride. Pralatrexate Pralatrexate Pralatrexate Pralatrexate d) (2S)-2-[[4-[(1RS)-1-[(2-amino-4-hydroxypteridin-6-yl) methyl] but-3-ynyl] benzoyl] amino] pentanedioic acid. 1181 Pralatrexate 1182 1183 1184 1185 1186 1187 1188 1189 1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200 1201 1202 1203 1204 Pramipexole dihydrochloride Pramipexole dihydrochloride Pramipexole dihydrochloride Pramipexole Pramipexole Pramiprexole dihydrochloride Pramiprexole dihydrochloride Pramiprexole dihydrochloride Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel Prasugrel e) (2R)-2-[[4-[(1RS)-1-[(2, 4-diaminopteridin-6-yl) methyl] but-3-ynyl] benzoyl] amino] pentanedioic acid. a) N-[(6R)-2-Amino-4,5,6,7-tetrahydro-1,3-benzothiazol-6-yl]propanamide.) b) (6R) -4,5,6,7-tetrahydro-1,3-benzothiazol-2,6-diamine. c) (S)-4,5,6,7-tetrahydro-N-6-PROPYL-2,6-Benxothiaxolediamene dihydrochloride. Pramipexole impurity A (Diamine) Pramipexole impurity B (Disubstituted) a) (S)-2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole. b) (S)-2-Amino-6-propionamido tetrahydro benzothiazole. c) (R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine. a)2-Bromo-1-cyclopropyl-2-(3-fluorophenyl)ethanone b)2-Bromo-1-cyclopropyl-2-(4-fluorophenyl)ethanone c)2-Bromo-1-cyclopropyl-2-phenylethanone d)1-Bromo-1-(2-fluorophenyl)-2-propanone e)Cyclopropyl 3-Fluorobenzyl Ketone f)Cyclopropyl 4-Fluorobenzyl Ketone g)1-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-1,2,5,6-tetrahydro-4-mercapto-3pyridineacetic Acid Sodium Salt h)Cyclopropyl 2-Fluorobenzyl Ketone i)Cyclopropyl 2-Fluorophenyl Diketone j)Defluoro Prasugrel Hydrochloride k)Descyclopropyl-2-oxopropyl Prasugrel l)m-Fluoro Prasugrel Hydrochloride m)p-Fluoro Prasugrel Hydrochloride n)p-Fluoro Prasugrel Thiolactone (Mixture of Diastereomers) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1205 Prasugrel Prasugrel hydrochloride o)m-Fluoro Prasugrel Thiolactone (Mixture of Diastereomers) Prasugrel hydrochloride b) 5-(2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-3-vinyl-4,5,6.7a-tetrahydrothieno[3,2c]pyridine-2-yl acetate. Lactam Impurity Lactose Conjugate Imp N-(3-chloro-4-hydroxyphenyl)acetamide 1-(4-Hydroxyphenyl)ethanone 1-(4-Hydroxyphenyl)ethanone oxime 4-(acetylamino)phenyl acetate 1-(2-hydroxyphenyl)ethanone PREGABALIN IMPURITY(Lactose Conjugate Impurity) 3-Isobutylglutaric acid(diacid) (s)-4-Isobutyl-2-pyrrolidinone(Lactum) R-Isomer (supplied as racemic mixture) Pregabalin lactose conjugate (Pregabalin lactum-Lactose Adduct) : 1-[(R )-4(2-Methylpropyl)-2 oxo-pyrrolidin-1-yl]-4-o-β-D galactopyranosyl-D- glucose. A) (R)-3-(2-amino-2-oxoethyl)-5-methylhexanoic acid. B) (R)-3-(Aminomehtyl)-5-methyhexanoic acid. a) 1-Cyano-3-(1-methylethyl)guanidine. b) 4-chloroaniline. 4-Hydroxy Propafenone 5-Hydroxy propafenone Prothionamide Sulfoxide 1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216 1217 1218 1219 1220 1221 1222 1223 1224 1225 1226 1227 1228 1229 1230 1231 1232 1233 1234 1235 1236 PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN PREGABALIN Pregabalin Pregabalin Proguanil Proguanil Propafenone Propafenone Prothionamide Prulifloxacin pyridinium Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine a) 5-(2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-5,6.7a-tetrahydrothieno[3,2-c]pyridine-2(4H)one hydrobromide. a) 6-Fluoro-1-methyl-4-oxo-7-(1-piperazinyl)-4H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic acid. 3-hydroxy-N-methyl pyridinium dibenzo[b,f][1,4]thiazepin-11(10H)-one (IMPURITY G) 11-(piperazin-1-yl)dibenzo[b,f][1,4]thiazepine (IMPURITY B) Quetiapine impurity H/Quetiapine N-Oxide Quetiapine impurity I/QuetiapineDesethoxy Quetiapine impurity D/(Bis(dibenzothiazepinyl)piperazine Quetiapine impurity A Quetiapine impurity J "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1237 1238 1239 1240 1241 1242 1243 1244 1245 1246 1247 1248 1249 1250 1251 1252 1253 1254 1255 1256 1257 1258 1259 1260 Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetiapine Quetipine hemifumarate Quetipine hemifumarate Quetipine hemifumarate Rabeprazole sodium Rabeprazole sodium Rabeprazole sodium Rabeprazole sodium Rabeprazole Rabeprazole Rabeprazole Rabeprazole Rabeprazole Rabeprazole Raloxifene hydrochloride 1261 a)Methanone,[6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-oxido-1piperidinyl)ethoxy]phenyl]. Raltegravir potassium a) N-(4-Fluorobenzyl)-2-(2-aminopropan-2-yl)-1,6-dihydro-5-hydroxy-1-methyl-6-oxopyrimidine4-carboxamide. Raltegravir potassium c) N4-(4-Fluorobenzyl)-2-1[(2-hydrazino-2-oxoacetyl)amino]-1-methylethyl-5-hydroxy-1-methyl6-oxo-1,6-dihydro-4-pyrimidine carboxamide. Raltegravir potassium e) 5-Hydroxy-1-methyl-2-(1-mehyl-1-[(5-methyl[1,3,4]oxadiazol-2-carbonyl)-amino]-ethyl)-6oxo-1,6-dihydro pyrimidine-4-carboxylic acid benzylamide. Raltegravir potassium f) N1-[1-(4-[(4-Fluorobenzyl)amino]carbonyl-5-hydroxy-1-methyl-6-oxo-1,6-dihydro-2pyrimidinyl)-1-methylethyl]ethanediamide. a) Benzyl(cis,endo)-octahydrocyclopenta[b]pyrrole-2(S)-carboxylate hydrochloride. 1262 1263 1264 1265 1266 Quetiapine impurity N Quetiapine impurity O Quetiapine impurity P Quetiapine impurity S Quetiapine impurity T Quetiapine impurity U Quetiapine impurity V Quetiapine impurity W Phenyl-2-(phenyl thio) phenyl carbamate Phenyl-2-(phenyl thio) amine hydrochloride 2-Nitro phenylthio benzene a) Dibenzo-(1,4)-thiazepine-11(10H)-one. b) 11-(1-piperazinyl)dibenzo-(1,4)-thiazepine. c) 2-(4-Dibenzo[b,f]-[1,4]-thiazepine-11-yl-1-piperazinyl)ethanol hemifumarate. a) 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]mehtyl]thio]-1H-benzimidazole. b) 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]mehtyl]]-1H-benzimidazole. c) 4-(3-Methoxypropoxy)-3-methyl-2-chloromethyl-pyridine,hydrochloride. d) 1H-benzimidazole-2-thiol. Rabeprazole Impurity 1 Rabeprazole Impurity 2 Rabeprazole Impurity 3 Rabeprazole Impurity 4 Rabeprazole Impurity 5 Rabeprazole Impurity 6 Ramipril "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1267 1268 1269 1270 1271 1272 1273 1274 1275 1276 1277 1278 1279 1280 1281 1282 1283 1284 1285 1286 1287 1288 1289 1290 1291 1292 1293 1294 1295 1296 1297 1298 1299 Ramipril Ramipril Ramipril Ramipril Ramipril Ramipril Ramipril Ramipril Ramipril Ramipril Ramipril Ranitidine Ranitidine Ranitidine Ranitidine Ranitidine Ranitidine Ranitidine Ranitidine Ranitidine Rasagiline hydrchloride Rasagiline hydrchloride RBESARTAN Repaglinide Repaglinide Repaglinide Repaglinide Rifampicine Rilpivirine hydrochloride Rilpivirine hydrochloride Riluzole Riluzole Riluzole b) N-[1(S)-Carboethoxy-3-phenylpropyl]-(S)-alanine. c)(2S,3aS,6aS)-1[(S)-2-[[(S)-1-carboxy phenylpropyl] amino]propanoyl] octahydro cyclopenta[b]pyrrole-2-carboxylic acid.(EP-E) Ramipril Impurity A CRS, - EPCRS Ramipril Impurity B CRS, - EPCRS Ramipril Impurity C CRS, - EPCRS Ramipril Impurity D CRS, - EPCRS Ramipril impurity K Ramipril Impurity E Ramipril Impurity F Ramipril Imp O Ramipril Imp G Compound No 1 Compound No 2 Compound No 3 Compound No 5 Compound No 7 Compound No 8 Compound No 9 Compound No 11 Compound No 12 a) (R)-2,3-Dihydro-1H-inden-1-amine hydrochloride. b) (IS)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine hydrochloride. RBESARTAN PROPYL ANALOUGE a) (3-ethoxy-4-ethoxycarbonyl-phenyl acetic acid).(USPRCB)(EP-B) b) (S)-3-Methyl-1-[2-(1-piperidinyl)phenyl]butylamine,N-acetyl-L-glutamate salt (USPACA) c) Ethyl 2-ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino-2oxoethyl]benzoate.(EP-D) d) 4-(carboxymethyl)-2-ethoxybenzoic acid.(EP-A) 25-Deacetyl Rifampicine a)4-Cyanoaniline. A) (E)-3-(4-(2-(4-Cyanophenylamino) pyrimidin-4-ylamino)-3,5-dimehtyl phenyl) acrylamide. a)4-Trifluro methoxy aniline. b) Thiourea[4-Triflouromethoxyphenyl]. c) 4-Bromo-6-(trifluoromethoxy)-2-benzothiazolamine. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1300 1301 1302 1303 1304 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1317 1318 1319 1320 1321 1322 1323 1324 1325 1326 1327 1328 1329 Rimonabant Rimonabant Rimonabant Rimonabant Rimonabant Ritonavir a) 5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-pyrazole-3-carboxylid acid. d) 5-(4-chlorophenyl)-1-(2,4-dichlorohenyl)-4-methyl-pyrazole-3-carboxamide) c) 5-(4-Chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-pyrazole-3-carbronylpiperidine e) N-Piperidino-1-(2,4-dichlorophenyl)-5-phenyl-4-methyl-pyrazole-3-carboxamide. f) N-Piperidino-5-(3-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-pyrazole-3-carboxamide. a) γ-(S)-Amino α-(1S)-(thiazolylmethyloxycarbonyl)-amino-(2-phenylethyl)-(S)-benzene butnol. c) N-[[(methyl[[2-(1-methylethyl)-4-thizoyl]mehtyl]amino]carbonyl]-L-valine. Ritonavir Ritonavir Rivastigmine Rivastigmine Rivastigmine Rivastigmine hydrogen tartrate Rivastigmine hydrogen tartrate Rizatripta Rizatriptan benzoate Rizatriptan benzoate Rizatriptan Roflumilast Roflumilast Roflumilast Roflumilast Roflumilast Ropinirole Hydrochloride Ropinirole Hydrochloride Ropinirole Hydrochloride Ropinirole Hydrochloride Ropinirole Hydrochloride Ropinirole hydrochloride Ropinirole hydrochloride Ropinirole hydrochloride d) (2S)-N-[(1S,2S,4S)-1-benzyl-2-hydroxy-4-[[(2S)-3-methyl-2-[[methyl[[2-(1methylethyl)thiazol-4-yl]mehtyl]carbamoyl]amino]butanoyl]amino]-5-phenylpentyl]-3-methyl-2[[methyl[[2-(1-methylethyl)thiazol-4-yl]methyl]carbamoyl]amino]butanamide.(USPRCT) Rivastigmine Rivastigmine Impurity-E 3-Acetylphenyl ethyl(methyl)carbamate.(Related compound D) a) 3-(1S)-1-[Dimethylamino] ethyl phenyl dimethylcarbamate. b) (S)-3-[1-Dimethylamino] ethyl phenol.(Phenol imp). Rizatriptan-n-oxide a) N,N-Dimethyl-5-(1H-1,2,4-triazol-1-yl-methyl)-1H-indole-3-ethanamine N-oxide. b) 2-[5-(1H-1,2,4-triazol-1-yl-methyl)-1H-Inidole-3-yl]ethanol. Rizatriptan Dimer a) 3,4-Bis(cycloproplmethoxy)-N-(3,5-dichloropyridin-4-yl)benzamide, b) 3,5-Dichloropyrdin-4amine. c) 3-(Cyclopropylmethoxy)-4-(difluoromethoxy) benzoicacid, d) N-(3,5-Dichloropropyridin-4-yl)-3,4-bis(difluoromethoxy)benzamide. e) 3-(Cyclopropylemthoxy)-N-(3,5-dichloro-4-pyridinyl-oxide)-4-difluoromethoxy)benzamide.4(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-3-(difluoromethoxy)benzamide Monopropyl ropinirole (CAS No.106916-16-9) N-hydroxyropinirole (CAS No.954117-22-7) Ropinirole N-oxide Ropinirole oxime Ropinirole indole derivative a) 4-(2-Dipropylamino-ethyl)-1H-indole-2,3-dione hydrogen chlorode. b) 2-(2-Oxo-1,3-dihydro-4-indolyl)ethyl-p-toulenesulphonate. c) Maleic acid. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1330 1331 1332 1333 1334 1335 1336 1337 1338 1339 Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin a)5’-O-tert-Butyldimethylsilyl Rosuvastatin Lactone b) Desfluoro Rosuvastatin Sodium Salt c) N-Desmethyl Rosuvastatin Disodium Salt Monohydrate d)N-Desmethyl Rosuvastatin Lactone e) Ethyl 4-(4-Fluorophenyl)-6-isopropyl-2-amino-pyrimidine-5-carboxylate f) Ethyl 4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylsulfonamido)pyrimidine -5-carboxylate g) Ethyl 4-(4-Fluorophenyl)-6-isopropyl-2-(methylsulfonyl)pyrimidine-5-carboxylate h) Ethyl 4-(4-Fluorophenyl)-6-isopropyl-2-methylthiopyrimidine-5-carboxylate i) N-[4-(4-Fluorophenyl)-5-formyl-6-(1-methylethyl)-2-pyrimidinyl]-N-methylmethane sulfonamide Rosuvastatin k) (4R,6S)-6-[(1E)-2-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2 [methyl (methyl sulfonyl )amino]-5pyrimidinyl]ethenyl]-2,2-dimethyl-1,3-dioxane -4-acetic Acid Rosuvastatin l) Methyl 4-(4-Fluorophenyl)-6-isopropyl-2-[N-methyl-N-(methylsulfonyl)amino] pyrimidine-5carboxylate m)Methyl 6-(4-Fluorophenyl)-4-isopropyl-2-methylthio-1,4-dihydropyrimidine -5-carboxylate n)Methyl 4-(4-Fluorophenyl)-6-isopropyl-2-(methylamino)pyrimidine-5-carboxylate 0)Methyl 4-(4-Fluorophenyl)-6-isopropyl-2-(methylsulfonyl)pyrimidine- 5carboxylate p)Methyl 4-(4-Fluorophenyl)-6-isopropyl-2-(methylthio)pyrimidine-5-carboxylate q) 3-Oxo RosuvastatinSodium Salt r) 5-Oxo Rosuvastatin s) Rosuvastatin Allyl Ester t) (3R,5R)-RosuvastatinSodium Salt 3-Hydroxy 5-keto Rosuvastatin 5-Hydroxy 3-keto Rosuvastatin Dehydro Rosuvastatin (Rosuvastatin dehydro acid) Rosuvastatin Diastereomer impurity ROSUVASTATIN CALCIUM ANTI ISOMER Rosuvastatin ethyl ester Rosuvastatin Lactone Desfluoro Rosuvastatin calcium salt 3S,5S Rosuvastatin 3R,5R Rosuvastatin 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 1350 1351 1352 1353 1354 1355 1356 1357 1358 1359 1360 1361 Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium j) N-[4-(4-Fluorophenyl)-5-hydroxymethyl-6-isopropylpyrimidin-2-yl]-Nmethylmethanesulfonamide "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1362 1363 1364 1365 Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin Calcium Rosuvastatin calcium 3S,5R Rosuvastatin 5-keto Rosuvastatin Diastereomer Lactone Rosuvastatin calcium B) (3R, 5S, E)-mehtyl 7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl methyl sulfonamido) pyrimidin-5yl)-3,5-dihydroxyhept-6-enoate.(H-RSVRC03) Rosuvastatin calcium C) N-(4-(4-fluorophenyl)-5-((E)-2-((2S, 4R)-4-hydroxy-6-oxo-tetrahydro-2H-pyran-2-yl) vinyl)-6isopropylpyrimidin-2-yl)-N-methyl methane sulfonamide. Rosuvastatin calcium D) (3R, 5R, 6E)-7-(4-(4-Flurophenyl)-6-(1-methylethyl) 1-2-[methyl (methylsulfonyl) amino]-5pyrimidinyl]-3,5-dihydroxy-6-heptanoic acid calcium salt(2:1). a) Ethyl1-[(2,6-Difluorobenzyl)-1H-1,2,3-triazole-4-carboxylate. b) 1-[(2,6-Difluorophenyl)-methyl]-1H-1,2,3-triazole-5-carboxamide. a) 8-Chloro-6, 11-(4-piperidinylidene)-5H-benzo [5,6]cyclohepta[1,2-b] pyridine. 1366 1367 1368 1369 1370 1371 1372 1373 1374 1375 Rufinamide Rufinamide Rupatadine Fumarate Saquinavir mesilate Saquinavir mesilate Saquinavir mesilate Saquinavir mesilate 1376 1377 1378 1379 1380 1381 1382 1383 1384 1385 1386 1387 Saxagliptin hydrochloride Saxagliptin hydrochloride Saxagliptin hydrochloride Saxagliptin hydrochloride Saxagliptin hydrochloride Saxagliptin hydrochloride secnidazole Sertraline hydrochloride Sertraline hydrochloride Sertraline hydrochloride Sertraline hydrochloride A) (R)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl methyl sulfonamido)pyrimidin-5-yl)-3hydroxy- 5-oxohept-6-enoic acid.(H-RSVRC01) a) (2R)-N1-[(IS,2R)-1-benzyl-3-[(3S,4aS,8aS)-3-[(1,1-dimethylethyl)carbamoyl]octahydroisoquinolin-2(1H)-yl]-2-hydroxypropyl]-2-[(quinolin-2ylcarbonyl)amino]butanediamide.(EP-D) b) Ethyl(2S)-4-amino-4-oxo-2-[(quinolin-2-ylcarbonyl)amino]butanoate.(EP-B) c) (2S)-4-amino-4-oxo-2-[(quinolin-2-ylcarbonyl)amino]butanoic acid.(EP-A) d) (3S,4aS,8aS)-2-[(2R,3S)-3-amino-2-hydroxy-4-phenylbutyl]-N-(1,1dimethylethyl)decahydroisoquinoline-3-carboxamide.(EP-C) A) (1S,4S,6R,7S)-4-(3-hydroxytricyclo[3.3.1.133,7]dec-1-yl)hexahydro-1Hcyclopropa[4,5]pyrrolo[1,2-a]pyrazin-3,6-dione a) (1S,4S,6R,7S)-4-(3-hydroxytricyclo[3.3.1.133,7]dec-1-yl)-6-iminooctahydro-3Hcyclopropa[4,5]pyrrolo[1,2-a]pyrazin-3-one b) (S)-N-Boc-3-hydroxyadamantylglycine-L-cis-4,5methanoprolinamide. d) (S)-N-Boc-3-hydroxyadamantylglycine-L-cis-4,5- methanoprolinamide. 2-methyl-5-nitro-1H-imidazole (Impurity A) a) (+/-)-Cis-4-phenyl-1,2,3,4-tetrahydro-N- methyl-1-napthalenamine hydrochloride (EP-B) b) (D)- Mandelic acid.(EP-E) c) (+/-)-Cis-4(4-chlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine hydrochloride(EPC) d) (+/-)-4-(3,4-Dichlorophenyl)-3,4-dihydro-1(2H)-napthalenone.(EP-F) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1388 Sertraline hydrochloride Sertraline hydrochloride e) (+/-)-4-(3,4-Dichlorophenyl)-3,4-dihydro-1(2H)-napthalenone oxime Sertraline hydrochloride g) (1R,4R)-Cis-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride.(EP-G) Impurity A Impurity-B Impurity-C Impurity- D& F mixture PANTOPRAZOLE N-OXIDE 1389 1390 1391 1392 1393 1394 1395 1396 1397 1398 1399 1400 1401 1402 1403 1404 1405 Sertraline Hydrochloride Sesqui hydrate Impurities Sesqui hydrate Impurities Sesqui hydrate Impurities Sesqui hydrate Impurities Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate Sildenafil Citrate 1406 Silodosin 1407 1408 Silodosin Silodosin 1409 Simvastatin 1410 f) (1S,4R)-Trans-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrrochloride.(EP-A) a) 5-{2-Ethoxy-5-[(4-{[4-ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydro-1H-pyrazolo[4,3d]pyrimidin-5-yl)phenyl]sulfonyl}piperazino)sulfonyl]phenyl}-1-methyl-3-propyl-6,7-dihydro-1HPyrazolo [4,3-d]Pyrimidin-7-one. b) 4-(2-Ethoxy benzamido)-1-mehtyl-3n-propyl-pyrazole-5-carboxamide. c) 4-{[4-Ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydro-1H-pyrazolo[4,3-d]pyrimidin-5yl)phenyl]sulfonyl}-1-methylhexahydropyrazin-1-ium-1-olate. d) 4-Ethoxy benzoic acid. e) 2-Ethoxy benzoic acid. f) 3-Ethoxy benzoic acid. g) 4-Ethoxy -3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5yl)benzenesulfonic acid. h) 5-(2-Ethoxy phenyl)-1-methyl-3n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidine-7-one. i) 1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidine-5-yl)-4-ethoxy phenyl]sulfonyl]-piperazine. j) 1-Methyl-4-nitro-3-propyl-1H-pyrazole-5-carboxamide. k) 5-{2-Ethoxy-5-[(4-methypiperzino)sulfonyl]phenyl}-3-ethyl-1-methyl-6,7-dihydro-1Hpyrazolo[4,3-d]pyrimidin-7-one. a) (R)-1-(3-Hydroxypropyl)-5-(2-{2-[2-(2,2,2-trifluoro-ethoxy)phneoxy]-ethylamino}-propyl)-2,3dihydro-1H-indole-7-carbonitrile. b) (R)-3-(5-(2-Aminopropyl)-7-cyanoindoin-1-yl)propyl benzoate tartate. c) (R) -3-{7-Cyano-5-[2-({2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl}amino)proply]-2,3-dihydro1H-indol-1-yl}propyl benzoate. a) (1S,3R,7S,8S,8AR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxotetrahdro-2H-pyran-2-yl]ethyl]-3,7dimehyl-1,2,3,7,8,8A-hexahydronapthalen-1-yl(2S)-2-methylbutanoate. "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com Simvastatin 1411 1412 1413 1414 1415 1416 1417 1418 1419 1420 1421 1422 1423 1424 1425 1426 1427 1428 1429 1430 1431 1432 1433 1434 1435 1436 1437 1438 1439 1440 1441 1442 Simvastatin Simvastatin Simvastatin Simvastatin Simvastatin Simvastatin Simvastatin Simvastatin Simvastatin Simvastatin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin Sitagliptin phosphate monohydrate Sitagliptin phosphate monohydrate Solifenacin succinate Solifenacin succinate Solifenacin succinate Solifenacin Solifenacin Solifenacin b) (3R,5R)-7-[(1S,2S,6R,8S,8AR)-8-[(2,2-Dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8AHexahydronapthlen-1-yl]-3,5-dihydroxyheptanoic acid. Simvastatin hydroxy acid Simvastatin acetate ester Anhydro Simvastatin SIMVASTATIN IMPURITY A SIMVASTATIN IMPURITY B (Acetyl Simvastatin) SIMVASTATIN IMPURITY C SIMVASTATIN IMPURITY D SIMVASTATIN IMPURITY G (Methylene Simvastatin) SIMVASTATIN METHYL ESTER IMP SIMVASTATIN IMP-F 2,5-DIfluro analogue of Sitagliptin 2,4-DIfluro analogue of Sitagliptin 3,4-DIfluro analogue of Sitagliptin Impurity A 5-amino-1H-pyrazole-4-carboxamide (5334-31-6) Impurity B:5-(formylamino)-1H-pyrazole-4-carboxamide (22407-20-1) Impurity C:5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide (1346604-03-4 Impurity E: Ethyl 5-(formylamino)-1Hpyrazole-4-carboxylate - (31055-19-3) a)Sitagliptin (S)-Isomer Phosphate Salt b)Sitagliptin Enamine Impurity c)Sitagliptin Acid d)Sitagliptin Ketoamide Impurity e)Sitagliptin N-Acetyl Impurity f)Sitagliptin Triazole Hydrochloride a)(3R)-3-Tert butoy carbonylamino-4-(2,4,5-trifluorophenyl)-butanoic acid b)Tert-butyl®-4-(3-triflouromethyl)-5,6-dihydo-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5trifluorophenyl)-4-oxobutane-2yl-carbamate. a) 1-Phenyl-3,4-dihydro isoquinoline. b) (IS)-1-Phenyl-1,2,3,4-tetrahydro isoquinoline. c)(1S)-3,4-di-dihydro-1-phenyl-2-(1H)-isoquinoline carboxylic acid(3R)-1-azabicyclo[2.2.2]oct-3yl ester N-oxide. N- Oxide impurity of Solifenacin (Solifenacin imp B) SOLIFENACIN SUCCINATE IMPURITY A SOLIFENACIN SUCCINATE IMPURITY B "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1443 1444 1445 1446 1447 1448 1449 1450 1451 1452 1453 Solifenacin Sorafenib tosylate Stavudine Stavudine Stavudine Stavudine Stavudine Sulfamethoxazole Sulfamethoxazole Sulfamethoxazole Sulfamethoxazole Tadalafil 1454 b) (6R-12aS)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4methylenedioxyphenyl)pyrazino[2,1:6]pyrido[3,4-6]indole-1,4-dione. Tadalafil c) ) (6S-12aS)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4methylenedioxyphenyl)pyrazino[2,1:6]pyrido[3,4-6]indole-1,4-dione. Tadalafil d) (6S-12aR) -2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)pyrazino[2,1:6] pyrido [3,4-6] indole -1,4-dione. Telmisartan b) Methyl 4’-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole-1yl]methyl]biphenyl-2-carboxylate. c) 4-methyl-6-(1-Methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole.(EP-A) 1456 1457 Telmisartan Telmisartan 1460 1464 1465 1466 1467 1468 d) 1-[(2’-Carboxybiphenyl-4-yl)methyl]-4-methyl-2-propyl-1H-benzimidazol-6-carboxylic acid.(EP-E) Telmisartan e) 4’-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1yl]methyl]biphenyl-2-carboxamide.(EP-F) Telmisartan (f) 4’-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1yl]methyl]biphenyl-2- carbonitrile. (EP-G) (g) Methyl 4’-(bromo methyl)biphenyl-2-carboxyalte. 1461 1462 1463 a) (IR,3R)-Methyl 1,2,3,4-tetrahydro-2-chloroacetyl-(3,4-mehylenedioxyphenyl)-9H-Pyrido-[3,46]indole-3-carboxylate. Tadalafil 1455 1458 1459 SOLIFENACIN SUCCINATE IMPURITY c a) 4-Chloro-3-(trifluoromethyl)-benzamine. a) 1-(2-Deoxy-beta-D-ribofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione. b) 5-Methylpyramidine-2,4(1H,3H)-dione. c)3’,5’-Anhydro thymidine. d) 3’,5’-Di-(O-mesyl)-thymidine. b) 5’Benzoyl-2’,3’-didehydro-3’-deoxythymidine. Sulfamethoxazole Impurity B Sulfamethoxazole Impurity C Sulfamethoxazole Impurity D Sulfamethoxazole Impurity E Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan (h) 4’[[4-Methyl-6-(1-(methyl biphenyl-2-carboxylicacid)-1H-benzimidazol-2-yl)-2-propyl-1Hbenzimidazol-1-yl]methyl]biphenyl-2-carboxlicacid. i) Telmisartan HCl j) Telmisartan EP Impurity B k) Telmisartan EP Impurity C l) Telmisartan EP Impurity H "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1469 1470 1471 1472 1473 1474 1475 1476 1477 1478 1479 1480 1481 1482 1483 1484 1485 Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Telmisartan Temozolamide Temozolamide Temozolamide Temozolamide Temozolomide Tenofovir disoproxil fumarate 1486 Tenofovir disoproxil fumarate 1487 1488 1489 1490 1491 1492 1493 1494 1495 1496 1497 1498 1499 Tenofovir disoproxil fumarate Tenofovir disoproxil fumarate Terbinafine hydrochloride Terbinafine hydrochloride Terbinafine hydrochloride Tetrabenazine Tetrabenazine Tetrabenazine Theophylline Theophylline Theophylline Theophylline m) Telmisartan Methyl Ester n) Telmisartan Ethyl Ester o) Telmisartan Bromo Acid p) Telmisartan Bromo Amide q) Telmisartan Bromo Ethyl Ester r) Telmisartan Bromo Methyl Ester s) Telmisartan Bromo Nitrile Impurity t) Telmisartan Hydroxy Methyl Ester u) Telmisartan Methoxy Methyl Ester Telmisartan EP Impurity-B Telmisartan Impurity-C TELMISARTAN TER-BUTYL ESTER a) 5-Amino-1H-imidazole-4-carboxamide hydrochloride. b) 4-Nitro phenol. c) 5-Amino-1-(N-Methyl carbamoyl)imidazole-4-carboxamide. Cyanotemozolamide Temozolomide Related Compound C g) [[(IR)1-(6-Amino-9H-purin-9-yl)propan-2-yl oxy]methylphosphonyl]methyl isopropyl carbonate. h) (R)-[[2-(6-Amino-9H-purin-9-yl)-1-methylethoxy]methyl]phosphonic acid Isopropoxycarbonyl oxymethyl ester iso0propyl ester furmarate. l) 9-Propenyl adenine. m) [[(1S)-2-(6-Amino-9H-purin-9-yl)-1-methyl ethoxy]methyl]phosphonicacid disoproxil fumarate. a) N-methyl-C-(naphthalene-1-yl)methanamine.(EP-A) b) (2Z)-N-6,6-trimethyl-N-(naphthalene-1-ylmethyl)hept-2-en-4-yn-1-amine.(EP-B) c) 1-Bromo-6,6-dimethyl hept-2-ene-4-yne. a) (3R, 11bs) and (3S, 11B-Hexahydro-9, 10-dimethoxy-3-(1-methypropyl)-2Hbenzo[a]quinolizin-2-one. b) 6, 7-Dimethoxy-3, 4-dihydro isoquinoline hydrochloride. Theophylline impurity A Theophylline impurity B Theophylline impurity C Theophylline impurity D "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1500 1501 1502 1503 1504 1505 1506 1507 1508 1509 1510 1511 1512 1513 1514 Tiagabine hydrochloride Tiagabine hydrochloride Tiagabine hydrochloride Tibolone Tilorone hydrochloride Tilorone hydrochloride TIMOLOL TIMOLOL TIMOLOL Tioconazole Tioconazole Tolterodine tartrate Tolterodine tartrate Tolvaptan Tolvaptan Tolvaptan 1515 Tolvaptan 1516 1517 1518 1519 1520 1521 Topiramate Torsemide Torsemide Torsemide Torsemide Torsemide 1522 Torsemide 1523 1524 1525 1526 1527 1528 1529 Tramadol Tramadol Tramadol Tramadol Tramadol Tramadol b) Bis(3-methyl-2-thienyl)methanone. c) R)-Ethyl 1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]-3-piperidine carboxylate. d) (S)-(+),(R)-(-)-1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]nipectoic acid.hydrochloride. Tibolone a) 2, 7-Dihydroxy-fluoren-9-one. b) 9-Fluorenone. TIMOLOL IMP. D TIMOLOL IMP. B TIMOLOL IMP. G Tioconazole Related Compound-A: Tioconazole Related Compound-B: a)2-[(1S)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol tartaric acid. b) 2-Methoxy-5-methyl-N,N-bis(1-methylethyl)-gamma-phenylbenzene propanamine. a)(4-Amino-2-methylphenyl) (7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-1-benzo[b]azepin-1yl)methanone. b) 2-methyl-4-[(2-methylbenzoyl)amino]benzoic acid. d) 4-[(5-Hydroxy-2,3,4,5-tetrahydro-1H-1-benzazepine-1-yl)carbonyl]-3-methylphenyl-2methylbenzamide. e) 7-Chloro-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-5-oxo-2,3,4,5-tetrahydro-1H-1benzazepine. a)2,3,4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranosyl sulphonylchloride. Torsemide Related compound B Torsemide Related compound C a) 4-(3-methylphenyl)-2H-Pyrido[4,3-e]-1,2,4-thiadiazin-3(4H)one1,1-dioxide.(EP-A b) [4-[(3-methylphenyl)amino]-3-pyridine sulfonamide](USPRACA)(EP-B) c) [N-[(n-butylamino)carbonyl]-4-[(3-methylphenyl)amino]-3pyridinesulfonamide].(USPRCB)(EP-D) d) N-[(n-ethylamino)carbonyl]-4-[(3-methylphenyl)amino]-3pyridinesulfonamide].(USPRCC)(EP-C) a)1,2-Dehydro Tramadol. b)1,6-Dehydro Tramadol c) O-Desmethyl Tramadol Hydrochloride d) (+)-O-Desmethyl Tramadol Hydrochloride. e) (-)-O-Desmethyl Tramadol Hydrochloride Tramadol Impurity E "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1530 1531 1532 1533 1534 Tramadol Tramadol Tramadol Trandolapril Trandolapril Trandolapril Tramadol Impurity A Tramadol HCL USP RS Tramadol Related Compound A and B ( USPRS) a) N-[(IS)-1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanine. b) Benzyl(2S,3aR,7aS)-octahydroindole-2-carboxylate. Trandolapril d) Ethyl(2s)-2-[(3R,5aS,9aR)-3-methyl-1,4-dioxoperhydropyrazino[1,2-a]indol-2-yl]-4phenylbutanoate.(EP-D) Impurity B Impurity D 4 - Aminomethylcyclohex-1-enecarboxylic Acid 4 - Aminomethyl Benzoic Acid Trospium Impurity-D, URAPIDIL-IMPURITY 1 URAPIDIL-IMPURITY 2 URAPIDIL-IMPURITY 3 1-(3-chloropropyl)-4-(3-bromophenyl)-piperazine 1-(3-bromopropyl)-4-(3-chlorophenyl)-piperazine a) 2-Amino-1,9-dihydro-6H-purin-6-one.(EP-A) b) 2-Amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-Purin-6-one. (EP-B) c) N,N-Dimethylpyridin-4-amine.( EP-G) f) 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl]N-methyl-L-valinate.(EP-R) g) 2-[[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl L-alaninate.(EP-H) i) 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)Methoxy]ethyl N-formyl-L-valinate. h) 2-[[2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)Methyl]oxy]ethyl isoleucinate. k) 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl) methoxy]ethyl D-valinate. a) 9-((1,3-Dihydroxy propan-2-yloxy)methyl)-2-amino-1H-purin-6(9H)-one. (USPRACA). Ganciclovir (Valganciclovir Related Compound-A) Guanine (Valganciclovir Related Compound-B) Methoxymethylguanine(Valganciclovir Related Compound-C) Isovalganciclovir Monoacetoxyganciclovir(Valganciclovir Related Compound-E) Bis-valine easter of ganciclovir (Valganciclovir Related Compound-F) 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1547 1548 1549 1550 1551 1552 1553 1554 1555 1556 1557 1558 1559 1560 1561 1562 Tranexamic Acid Tranexamic Acid Tranxamic Acid Imp - C Tranxamic Acid Imp - D Trospium Urapidil Urapidil Urapidil Urapidil Urapidil Valaciclovir hydrochloride Valaciclovir hydrochloride Valaciclovir hydrochloride Valaciclovir hydrochloride Valaciclovir hydrochloride Valaciclovir hydrochloride Valaciclovir hydrochloride Valaciclovir hydrochloride Valaciclovir hydrochloride Valganciclovir hydrochloride Valganciclovir Valganciclovir Valganciclovir Valganciclovir Valganciclovir Valganciclovir c) (2S,3aR,7aS)-1-[(2s)-2-[[(IS)-1-Carboxy-3-phenylpropyl]amino]-1-oxopropyl]octahydro-1HIndole-2-carboxylic acid.(EP-E) "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1563 1564 1565 1566 1567 1568 1569 1570 1571 1572 1573 1574 1575 1576 1577 1578 1579 1580 1581 1582 1583 1584 1585 1586 1587 1588 1589 1590 1591 1592 1593 1594 1595 Valganciclovir Valganciclovir Valganciclovir Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartan Valsartsn Valsartsn Valsartsn Vardenafil hydrochloride Vardenafil hydrochloride Venlafaxine Verapamil Verapamil Verapamil Ganciclovir monopropionate(Valganciclovir Related Compound-J) Ganciclovir mono-N-methyl valinate(Valganciclovir Related Compound-N) D-Valganciclovir a) N-(1-Oxopentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-valine benzyl ester.() () b) (S)-N-Butyryl-N-[[2’-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl]-valine. c) N-(1-Oxepentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-methyl]-D-valine. d)Methyl 2-(n-((2’-(1h-tetrazole-5-yl)biphenyl-4-yl)methyl)pentanamido)-3-methylbutanoate. a) Benzyl N-[(2’-(Trityltetrazol-5-yl-1,1’-biphenyl-4-yl]-methyl-2-amino-3-methylbutanoate b) Des(oxopentyl) Valsartan Benzyl Ester c) tert-Butyl 4-Methyl-2-biphenylcarboxylate d) 4-Hydroxy Valsartan(Mixture of Diastereomers) e) 4-Hydroxy Valsartan Benzyl Ester, Mixture of Diastereomers f) 4-Methyl-2-biphenylcarbonyl Chloride g) 5-(4-Methyl-2-biphenyl)tetrazole h) 4-Oxo Valsartan Benzyl Ester i) Trityl Valsartan n-Propyl Impurity Benzyl Ester j) Trityl Valsartan Sodium Salt k) Valsartan Benzyl Ester l) Valsartan n-Propyl Impurity m) Valsartan n-Propyl Impurity Benzyl Ester n) 5-[4’-Bromomethyl-(1,1’-biphenyl)-2-yl]-2-triphenylmethyl tetrazole o) 5-[4-(Dibromomethyl)[1,1-biphenyl]-2-yl]-2-(triphenylmethyl)-2H-tetrazole Valsartan Imp A Valsartan Imp B Valsartsn related compound A Valsartsn related compound B Valsartsn related compound C a) 2(2-ethoxyphenyl)-5-methyl-7-propyl-3,4-dihydroimidazo[5,1-f][1,2,4]triazin-4-one. b) 2-Ethoxy-5-[(4-methyl-1-piperazinyl)sulfinyl]phenyl-5-methyl-7-propylimidazol[5,1f][1,2,4]triazin-4(3H)-one. Venlafaxine Imp.F impurity A VP-1 impurity B VP-2 impurity C VP-3 "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1596 1597 1598 1599 1600 1601 1602 1603 1604 Verapamil Verapamil Verapamil Verapamil Verapamil Vilazodone Vildagliptin Vildagliptin Vildagliptin Voriconazole 1605 a) (2S,3R)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol. Voriconazole 1606 1607 1608 1609 1610 1611 1612 1613 1614 1615 1616 1617 1618 1619 1620 1621 1622 1623 1624 1625 1626 1627 1628 impurity D VP-4 impurity E VP-5 Impurity G VP-7 Impurity K VP-11 Impurity L VP-12 Vilazodone Impurity all a) (2R)-1-[[(3-hydroxy tricyclo-3.3.1.1(3.7)dec-1-yl)amino]acetyl]-2- pyrrolidine carboamide. b) (R)-1-[2-(3-Hydroxyadamantan-1-ylamino)acetyl]pyrrolidine-2- carboamide. c) 1-Aminoadamantane-3-ol. Voriconazole Zaltoprofen Zaltoprofen Zaltoprofen Zidovudine Zidovudine Ziprasidone Ziprasidone Ziprasidone Ziprasidone Ziprasidone Ziprasidone Zoledronic acid Zoledronic acid Zolmitriptan Zolmitriptan Zolmitriptan Zolpidem Zolpidem Zolpidem Zolpidem Zolpidem b) (2R,3S)/(2S,3R)-3-(5-Fluoro-6-chloro-pyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4triazol-1-yl)butane-2-ol. c) 1-(2,4-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone. a)2-(10,11-dihydro-10-oxo dibenzo[b,f]thiopin-2-yl)propanoic acid methyl ester. b) 2-(3-(Carboxymethy)-4-(phenylthio)phenyl)propanoic acid. c) 2-Propionyl-10,11-dihydrodibenzo[b,f]thiepin-10-one. a) Triphenyl methanol. b) 5-Methyl pyrimidine-2,4(1H,3H)-dione amine. a)6-Chloro-5-(2-chloroethyl)oxindole. b)1-(1,2-Benzisothiazol-3-yl)piperazine. Ziprasidone Related Comp A Ziprasidone Related Comp B Ziprasidone Related Comp D Ziprasidone Open ring Impurity a) Imidazole b) Ethyl imidazole-1-yl-acetate. a)(S)-N,N-dimethul-2-[5-(2-oxo-1-3-oxazolidin-4-yl methyl)-1H-indol-3-yl]ethylamin N-oxide. b) (S)-4-(4-Amino benzyl)-2-oxazolidinone hydrochloride. c) (4R)-4-[[3-[2-(Dimethyl amino)ethyl]-1H-Indol-5yl]methyl]-2-oxazolidinone. Zolpidem acid: 2-(6-Methyl-2-p-tolylimidazo[1,2-a]pyridin-3-yl) acetic acid.Zolpidem related compound A Zolpidem Related compound-B, Zolpidem Related compound-C Phenyl-2-(phenyl thio) amine HCl "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com 1629 1630 1631 1632 1633 1634 1635 1636 1637 1638 1639 Zolpidem Zonisamide Zonisamide Trimbutine 1-METHOXYDECANE IMP 3,4-dichlorobenzyl alcohol, 3-Hydroxy benzoic acid 3-METHOXY 2-METHYLBENZOIC ACID 3-METHOXY 2-METHYLBENZOIC ACID 3-METHOXY 2-METHYLBENZOIC ACID 4-hydroxy benzoic acid 2-Nitro phenylthio benzene a) 1,2-Benzisoxazole-3-methane sulfonic acid sodium salt. b) 1,2-Benzisoxazole-3-acetic acid. N-desmethyl Trimbutine 1 - METHOXYDECANE IMPURITY 3,4-dichlorobenzyl alcohol, 3-METHOXY 2-METHYLBENZOIC ACID 3-METHOXY 2-METHYL ANILINE (19500-02-8) AMMPK(CAS NO-912347-94-5) 4-hydroxy benzoic acid "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com "PROMAS HOUSE", 2nd floor, Plot No. R-877, TTC industrial Area, MIDC, Rabale, Navi Mumbai - 400 701 INDIA Tel.: 91-22-2769 4285-86-87 / 5769 4273 -74-75-76 / 2760 7007 Fax : 2760 2035 E-mail : info@promasindia.com,bmkale@promasresearch.com, enquiry@promasresearch.com