IPC/7035/IP-2010/AL-5
AMENDMENT LIST- 5 TO IP 2010
General Chapters
2.4.22.Optical Rotation and Specific Optical Rotation. Page 143
Para 6, line 6
Change from: per ml.
to: per 100 ml.
2.4.26. Solubility
Page 150
Insert before Benzyl Benzoate
Benzyl Alcohol. Soluble in water, miscible with ethanol (95 per cent) and with fatty and essential oils.
Dapsone. Page154
Change to: Dapsone. Freely soluble in acetone; soluble in dilute mineral acids; sparingly soluble in ethanol (95 per
cent) and very slightly soluble in water.
Famotidine. Page 156
Change to: Famotidine. Freely soluble in dimethylformamide and in glacial acetic acid; slightly soluble in methanol;
very slightly soluble in water; practically insoluble in acetone, in ethanol (95 per cent), in chloroform, in ether and in
ethyl acetate.
Fluocinolone Acetonide. Page 157
Change to: Fluocinolone Acetonide. Soluble in acetone and in ethanol; slightly soluble in chloroform and practically
insoluble in water and in light petroleum.
Isosorbide Mononitrate, Diluted. Page 159
Delete the requirement.
Rizatriptan Benzoate. Page 2839
Change to: Rizatriptan Benzoate. Soluble in methanol and in water; sparingly soluble in dimethyl sulphoxide and in
dimethylformamide; slightly soluble in ethanol (95 per cent) and in dichloromethane; insoluble in toluene, cyclohexane
and in hexane.
2.4.2. Atomic Absorption Spectrometry. Page 109
Insert at the end.
Calcium Solution AAS
Dissolve 1.001 g of calcium carbonate, previously dried to constant weight at 105°, in 25 ml of 1M hydrochloric acid,
boil to remove carbon dioxide and add sufficient water to produce 1000 ml.
Calcium Solution FP contains 400 μg of Ca in 1 ml.
Iron Solution AAS
Dilute sufficient quantity of iron standard solution with 0.2 M nitric acid to contain 4 μg of Fe in 1 ml.
Lithium Solution AAS
Dissolve 1.064 g of lithium carbonate in 5 ml of hydrochloric acid and add sufficient water to produce 100 ml.
Lithium Solution FP contains 2 mg of Li in 1 ml.
Potassium Solution AAS.
Dissolve 1.440 g of potassium chloride, previously dried to constant weight at 130°, in sufficient freshly distilled water
to produce 1000 ml.
Potassium Solution FP contains 600 μg of K in 1 ml.
Silver Solution AAS
Dissolve 0.790 g of silver nitrate in sufficient water to produce 1000 ml. Further dilute 1 volume of the resulting
solution to 100 volumes with water.
1 of 16
IPC/7035/IP-2010/AL-5
Silver solution AAS contains 5 μg of Ag in 1 ml.
Sodium Solution AAS
Dissolve 0.5084 g of sodium chloride, previously dried to constant weight at 130°, in sufficiently freshly distilled water
to produce 1000 ml.
Sodium Solution FP contains 200 μg of Na in 1 ml.
Strontium Solution AAS
Dissolve 1.685 g of strontium carbonate in 10 ml of a 50 per cent v/v solution of hydrochloric acid and add sufficient
water to produce 1000 ml.
Strontium Solution AAS contains 1 mg of Sr in 1 ml.
2.4.4. Flame Photometry. Page 110
Insert at the end.
Calcium Solution FP
Dissolve 1.001 g of calcium carbonate, previously dried to constant weight at 105°, in 25 ml of 1M hydrochloric acid,
boil to remove carbon dioxide and add sufficient water to produce 1000 ml.
Calcium Solution FP contains 400 μg of Ca in 1 ml.
Lithium Solution FP
Dissolve 1.064 g of lithium carbonate in 5 ml of hydrochloric acid and add sufficient water to produce 100 ml.
Lithium Solution FP contains 2 mg of Li in 1 ml.
Potassium Solution FP
Dissolve 1.440 g of potassium chloride, previously dried to constant weight at 130°, in sufficient freshly distilled water
to produce 1000 ml.
Potassium Solution FP contains 600 μg of K in 1 ml.
Sodium Solution FP
Dissolve 0.5084 g of sodium chloride, previously dried to constant weight at 130°, in sufficiently freshly distilled water
to produce 1000 ml.
Sodium Solution FP contains 200 μg of Na in 1 ml.
2.5.2. Dissolution Test. Page 189
Dissolution medium. Insert at the end,
For hard or soft gelatin capsules and gelatin-coated tablets that do not conform to the dissolution specification, repeat
the test as follows. Where water or a medium with a pH of less than 6.8 is specified as the medium in the individual
monograph, the same medium specified may be used with the addition of purified pepsin that results in an activity of
750,000 Units or less per 1000 ml. For media with a pH of 6.8 or greater, pancreatin can be added to produce not more
than 1750 Units of protease activity per 1000 ml.
4.2. General Reagents
Page 621
Insert before Zinc, Activated
Zinc Acetate, 0.25 M. Dissolve 54.9 g of zinc acetate in a mixture 600 ml of water and 150 ml of glacial acetic acid;
stir to dissolve the zinc acetate. While stirring, add 150 ml of ammonium hydroxide, cool to room temperature, adjust
the pH to 6.4 with ammonium hydroxide and dilute with water to produce 1000.0 ml.
4.3. Indicators and Indicator Test Papers
Insert before Metalphthalein. Page 625
m-Cresol Purple Solution: Dissolve 0.1 g of m-cresol purple in 13 ml of 0.01M sodium hydroxide, dilute to 100 ml
with water and mix.
4.5. Volumetric Reagents and Solutions.
Page 631,
2 of 16
IPC/7035/IP-2010/AL-5
Dioctyl Sodium Sulphosuccinate, 0.0005M Change to:
Dioctyl Sodium Sulphosuccinate, 0.005M. Dissolve 2.25 g of dioctyl sodium sulphosuccinate in warm water, cool
and dilute to 1000 ml with water. Standardise the solution in the following manner.
To 25.0 ml add 25 ml of a solution containing 20 per cent w/v of anhydrous sodium sulphate and 2 per cent w/v of
sodium carbonate, 50 ml of chloroform and 1.5 ml of bromophenol blue solution and mix. Titrate with 0.01M
tetrabutylammonium iodide until about 1 ml from the end point. Stopper the flask, shake vigorously for 2 minutes and
continue the titration, in increments of 0.05 ml, shaking vigorously and allowing the flask to stand for about 10 seconds
after each addition. Continue the titration until a blue colour just appears in the chloroform layer.
1 ml of 0.01M tetrabutylammonium iodide is equivalent to 0.004446 g of C20H37NaO7S.
Page 635
Insert before Titanium Trichloride, 0.1 M,
Tetrabutylammonium Iodide, 0.01M. Dissolve 4 g of tetrabutylammonium iodide in water and dilute to 1000 ml with
water. Standardise the solution in the following manner.
Pipette 25.0 ml of the solution into a flask, add 50.0 ml of 0.01 M silver nitrate solution, add 1.0 ml of 1 M nitric acid
and titrate the excess of silver nitrate with 0.01 M ammonium thiocyanate using 1 ml of ferric ammonium sulphate
solution as an indicator.
1 ml of 0.01 M silver nitrate is equivalent to 0.003694 g of C16H37IN.
5.2. Biological Indicators. Page 639
6.2. Identification. Line 8
Change from: 30° to 50°
to: 30° to 35°
Capsules. Page 721
Disintegration.
Soft Capsules. Line 3
Change from: and add a disc to each tube
to: The disc may be omitted if the capsules adhere to the disc or if it is likely to be attacked by the contents of
capsules.
Enteric Capsules.
Change to: Use the apparatus described under disintegration test (2.5.1), using one capsule in each tube. Operate the
apparatus for 2 hours without the discs in 0.1 M hydrochloric acid. No capsule shows sign of disintegration or of
rupture permitting the escape of the contents. Replace the medium in the vessel with mixed phosphate buffer pH 6.8.
When justified and authorized, a buffer solution of pH 6.8 with added pancreas powder (for example, 0.35 g of
pancreas powder per 100 ml of buffer solution) may be used. Add a disc to each tube and operate the apparatus for a
further 60 minutes.
If the capsules fail to comply because of adherence to the discs, the results are invalid. Repeat the test on a further 6
capsules omitting the discs.
Monographs
Alprazolam. Page 786
Identification. B, line 1 and 3
Change from: water
to: methanol
Alprazolam Tablets. Page 787
Dissolution. Chromatographic system, line 2
3 of 16
IPC/7035/IP-2010/AL-5
Change from: octadecylsilane
to: octylsilane
Amphotericin B. Page 820
pH. Delete the requirement.
Ampicillin Sodium.
Page 824
Dichloromethane. Reference solution (b).
Change to: Reference solution (b). A 0.02 per cent v/v solution of dichloromethane in internal standard solution.
Last para, lines 1 and 2
Change from: Calculate the percentage w/w of dichloromethane, assuming its relative density (2.4.29) to be 1.325 g
to: Calculate the percentage w/w of dichloromethane taking 1.325 g as its weight per ml (2.4.29).
Ampicillin Injection.
Page 825
Dichloromethane. Reference solution (b).
Change to: Reference solution (b). A 0.02 per cent v/v solution of dichloromethane in internal standard solution.
Last para, lines 1 and 2
Change from: Calculate the percentage w/w of dichloromethane, assuming its relative density (2.4.29) to be 1.325 g
to: Calculate the percentage w/w of dichloromethane taking 1.325 g as its weight per ml (2.4.29).
Atenolol. Page 847
Related substances. Change to:
Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Dissolve 100 mg of the substance under examination in the mobile phase and dilute to 100.0 ml with the
mobile phase. Dilute 1.0 ml of the solution to 10.0 ml with the mobile phase.
Reference solution. Dilute 1.0 ml of the test solution to 100.0 ml with the mobile phase.
Chromatographic system
– a stainless steel column 30 cm x 3.9 mm, packed with octadecylsilane bonded to porous silica (5 µm),
– mobile phase: dissolve 1.1 g of sodium 1-heptanesulfonate and 0.71 g of anhydrous dibasic sodium phosphate
in 700 ml of water. Add 2 ml of dibutylamine, and adjust to pH 3.0 with 0.8 M phosphoric acid, add 300 ml of
methanol,
– flow rate: 0.6 ml per minute,
– spectrophotometer set at 226nm,
– injection volume: 50 µl.
Inject the reference solution. The test is not valid unless the column efficiency is not less than 5000 theoretical plates
and the tailing factor is not more than 2.0.
Inject the reference solution and the test solution. Run the chromatogram 6 times the retention time of the principal
peak. In the chromatogram obtained with the test solution, the area of any secondary peak is not more than 0.25 times
the area of the principal peak in the chromatogram obtained with reference solution (0.25 per cent). The sum of areas of
all the secondary peaks is not more than 0.5 times the area of the principal peak in the chromatogram obtained with
reference solution (0.5 per cent).
Atenolol Tablets. Page 848
Assay. Lines 5 and 6
Change from: sintered glass funnel (Porosil G3)
to: fine glass micro-fibre filter paper (Whatman GF/C)
Atorvastatin Tablets. Page 850
Insert before Other tests.
Uniformity of Content. (For tablets containing 10 mg or less) Complies with the test stated under Tablets.
Determine by liquid chromatography (2.4.14) as described in the Assay using the following test solution.
4 of 16
IPC/7035/IP-2010/AL-5
Test solution. Transfer one tablet in 50.0-ml volumetric flask, add 3 ml of water and allow to disperse the tablet in
water, add 20 ml of methanol and mix with the aid of ultrasound, make up to volume with methanol and filter. Dilute
10.0 ml of the filtrate to 25.0 ml with the solvent mixture.
Azithromycin Oral Suspension. Page 860
Assay. Solvent mixture.
Change from: 40 volumes of acetonitrile and 60 volumes of 3.484 per cent w/v solution of dipotassium hydrogen
phosphate with the pH previously adjusted to 6.5 with orthophosphoric acid.
to: 40 volumes of acetonitrile and 60 volumes of water.
Benzhexol Hydrochloride. Page 884
Related substances. Chromatographic system, mobile phase
Change to: a mixture of 200 volumes of water, 0.2 volume of triethylamine, adjusted to pH 4.0 with orthophosphoric
acid and 800 volumes of acetonitrile,
Calcitriol Capsules. Page 961
Assay. Test solution.
Change to: For capsules containing 0.25 µg or less calcitriol use the mixed contents of 10 capsules as test solution. For
capsules containing more than 0.25 µg of calcitriol, dilute a quantity of mixed contents of 10 capsules with the mobile
phase to obtain a concentration of 1.5 µg of calcitriol per ml.
Cefadroxil Oral Suspension. Page 2891
Related substances. Reference solution (c).
Change to: Reference solution (c). Dissolve 10 mg of 7- amino desacetoxycephalosphorinic acid RS (cefadroxil
impurity B RS ) in 10.0 ml of phosphate buffer pH 7.0 and dilute to 100.0 ml with mobile phase A . Dilute 5.0 ml of
this solution to 50.0 ml with mobile phase A.
Cefotaxime Sodium Injection. Page 1017
Water
Change to: Loss on drying (2.4.19). Not more than 3.0 per cent, determined on 1.0 g by drying in an oven at 105º.
Cefpodoxime Tablets. Page 1020
Dissolution. Line 13
Change from: cefpodoxime proxetil RS in the same medium
to: cefpodoxime proxetil RS prepared by dissolving in minimum quantity of methanol and diluted with the
dissolution medium.
Citric Acid Monohydrate. Page 1100
Calcium. Line 4
Change from: 10 ml
to: 15 ml
Colchicine and Probenecid Tablets. Page 1132
Assay. For colchicine, last line
Change from: taking 425 as the specific absorbance at 350 nm.
to: taking 440 as the specific absorbance at 350 nm.
Crosscarmellose Sodium. Page 1139
Identification. A. Line 1,
Change from: 0.00001 per cent
to: 0.0004 per cent
5 of 16
IPC/7035/IP-2010/AL-5
Dapsone. Page 1162
Related substances. Reference solution (b).
Change to: Reference solution (b). Dilute 2.0 ml of reference solution (a) to 10.0 ml with methanol.
Last para, line 8
Change from: reference solution (a) to: reference solution (a) (1.0 per cent)
Last line
Change from: reference solution (b) to: reference solution (b) (0.2 per cent)
Dicyclomine Tablets. Page 1206
Identification. B. Lines 4 to 6
Change from: Add a quantity of the powdered tablets containing 20 mg of Dicyclomine Hydrochloride
to: Add about 20 mg of extracted powder obtained in identification test A,
Activated Dimethicone. Page 1230
Assay. For polydimethylsiloxane – Lines 3 and 11
Change from: carbon tetrachloride
to: toluene
For silicon dioxide – Line 4
Change from: carbon tetrachloride
to: toluene
Line 6
Change from: n-hexane
to: toluene
Disodium Edetate. Page 1234
Impurity A. mobile phase
Change to: mobile phase: 50 mg of ferric sulphate pentahydrate in 50 ml of 0.5 M sulphuric acid and add 750 ml of
water. Adjust the pH to 1.5 with 0.5 M sulphuric acid or 1 M sodium hydroxide. Add 20.0 ml of ethylene glycol and
dilute to 1000 ml with water.
After chromatographic system, para 1, line 4,
Change from: more
to: less
Donepezil Hydrochloride. Page 1248
Sulphated ash.
Change from: Sulphated ash (2.3.19).
to: Sulphated ash (2.3.18).
Donepezil Tablets. Page 1249
Dissolution. Change to:
Dissolution (2.5.2).
Apparatus No. 1,
Medium. 900 ml of 0.1 M hydrochloric acid,
Speed and time. 50 rpm and 45 minutes.
Withdraw a suitable volume of medium and filter.
Determine by liquid chromatography (2.4.14).
Test solution. Dilute the filtrate, if necessary, with the dissolution medium.
6 of 16
IPC/7035/IP-2010/AL-5
Reference solution. Dissolve an accurately weighed quantity of donepezil RS in the dissolution medium, dilute to
obtain a solution having a known concentration similar to expected concentration of test solution.
Chromatographic system as described under Assay using 50 µl injection volume.
Inject the reference solution and the test solution.
D. Not less than 75 per cent of the stated amount of C24H29NO3,HCl.
Doxofylline Tablets. Page 1254
Related substances. Last para, line 3
Change from: 0.2 times
to: 0.5 times
Line 4
Change from: (0.2 per cent)
to: (0.5 per cent)
Efavirenz, Emtricitabine and Tenofovir Tablets. Page 2904
Dissolution. Last para, line 1
Change from: Not less than 80 per cent
to: Not less than 75 per cent
Enoxaparin Sodium. Page 1276
Identification. A. After chromatographic system, para1
Change to: Inject the reference solution. The test is not valid unless the column efficiency is not less than 10000
theoretical plates for refractive index detector.
Benzyl alcohol. After chromatographic system, para 1and 2
Change to:
Inject the reference solution and the test solution. In the chromatogram obtained with the reference solution, calculate
the ratio (R1) of the height of the peak due to benzyl alcohol to the height of the peak due to the internal standard. In the
chromatogram obtained with the test solution, calculate the ratio (R 2) of the height of the peak due to benzyl alcohol to
the height of the peak due to the internal standard.
Calculate the percentage content (m/m) of benzyl alcohol using the following expression:
m = mass of the substance under examination, in grams.
The content is not more than 0.1 per cent of benzyl alcohol
Enoxaparin Injection. Page 1279
Anti-factor IIa activity. Lines 1 and 2
Change from: Not less than 20.0 and not more than 35.0 anti-factor IIa IU per mg.
to: Not less than 2000 and not more than 3500 anti-factor IIa IU per ml.
Anti-factor Xa to anti-factor IIa ratio. Line 2 and 4,
Change from: IU per mg
to: IU per ml
Ephedrine Oral Solution. Page 1281
Ethanol content. Reference solution (a), line 3
Change from: 5.0 per cent v/v of 1-propanol.
to: 3.0 per cent v/v of 1-propanol.
Reference solution (b).
Change to: Reference solution (b). A 3.0 per cent v/v solution each of internal standard and ethanol in water.
7 of 16
IPC/7035/IP-2010/AL-5
Erythromycin. Page 1290
Assay. Line 4
Change from: water
to: sterile phosphate buffer pH 8.0
Erythromycin Tablets. Page 1291
Assay. Para 2, lines 2 and 3
Change from: 0.4 g of Erythromycin and triturate with 10 ml of sterile phosphate buffer pH 8.0
to: 0.25 g of Erythromycin and triturate with 10 ml of methanol.
Ethinyloestradiol Tablets. Page 1307
Assay. Delete the follwoing
Take 1 ml of this solution and dilute to 10 ml with the same solvent.
Fentanyl Citrate. Page 1339
Related substances. Reference solution (b). Add after reference solution (b),
To prepare degradation compound N-phenyl-1-(2-phenylethyl)piperidin-4-amine (fentanyl citrate impurity D).
After chromatographic system, para 2,
Change to: Inject reference solution (a) and the test solution. In the chromatogram obtained with the test solution the
area of any secondary peak is not more than the area of the principal peak in the chromatogram obtained with reference
solution (a) (0.25 per cent). The sum of the areas of all the secondary peaks is not more than twice the area of the
principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent). Ignore any peak with an area
less than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per
cent).
Fluoxetine Hydrochloride. Page 1369
Related substances. After chromatographic system, para 2, lines 6 to 8
Change from: the peak to valley ratio for fluoxetine impurity C is not greater than 1.1. If the ratio is greater than 1.1,
to: the peak to valley ratio for fluoxetine impurity C is not less than 11. If the ratio is less than 11,
Folic Acid. Page 1384
Related substances. Reference solution (b). Line 3
Change from: with the mobile phase.
to: with the same solution.
Reference solution (e). Line 3
Change from: with the mobile phase.
to: with the same solution.
After chromatographic system, para 1 , insert at the end
and for 2-amino-7-(chloromethyl)pteridin-4(1H)-one (folic acid impurity F) is about 2.2.
Framycetin Sulphate. Page 1388
Alcohols. Delete the requirement.
Glibenclamide. Page 1414
Assay. Line 4
Change from: red colour
to: pink colour
Hydrochloric Acid. Page 1450
Residue on evaporation. Insert at the end,
by evaporating to dryness on a water-bath and dry at 105°.
8 of 16
IPC/7035/IP-2010/AL-5
Dilute Hydrochloric Acid. Page 1450
Residue on evaporation. Insert at the end,
by evaporating to dryness on a water-bath and dry at 105°.
Hyoscine Butylbromide. Page 1466
Identification. Change to:
Identification.
A. Determine by infrared absorption spectrophotometry (2.4.6). Compare the spectrum with that obtained with
hyoscine butylbromide RS or with the reference spectrum of hyoscine butylbromide.
B. It gives the reactions of bromides (2.3.1).
Lamivudine and Zidovudine Tablets. Page 1561
Dissolution. Line 3
Change from: 50 rpm
to: 75 rpm
Related substances. Change to:
Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Disperse a quantity of the powdered tablets containing about 150 mg of Lamivudine in methanol and
dilute to 100.0 ml with methanol, filter.
Reference solution (a). A 0.01 per cent w/v solution of thymine in methanol.
Reference solution (b). A solution containing 0.3 per cent w/v of zidovudine RS and 0.15 per cent w/v of lamivudine RS
in methanol.
Chromatographic system
– a stainless steel column 25 cm x 4.6 mm, packed with octadecylsilane chemically bonded to porous silica
(5 μm),
– column temperature: 35°,
– mobile phase: A. a buffer solution prepared by dissolving 1.945 g of ammonium acetate in 900 ml of water,
adjusting to pH 3.8 with glacial acetic acid and diluting to 1000.0 ml with water,
B. methanol,
– flow rate: 1 ml per minute,
– a gradient programme using the conditions given below,
– spectrophotometer set at 270 nm,
– injection volume: 10 μl.
Time
(in min.)
0
10
25
40
45
Mobile phase A
(per cent v/v)
90
90
80
90
90
Mobile phase B
(per cent v/v)
10
10
20
10
10
Inject reference solution (b). The test is not valid unless the tailing factor of the lamivudine and zidovudine peaks is not
more than 2.0.
Inject reference solution (a) and the test solution. In the test solution, the content of thymine is not more than 2.0 per
cent and of any unknown impurity not more than 0.5 per cent. The sum of all the impurities is not more than 3.0 per
cent, calculated by area normalization.
Lamivudine, Nevirapine and Stavudine Dispersible Tablets. Page 1563
Usual strengths. Change to:
Usual strengths. Lamivudine 30 mg, Nevirapine 50 mg and Stavudine 6 mg; Lamivudine 60 mg, Nevirapine 100 mg
and Stavudine 12 mg.
9 of 16
IPC/7035/IP-2010/AL-5
Related substances. Change to:
Related substances. Determine by liquid chromatography (2.4.14).
NOTE — Prepare the solutions immediately before use.
Solvent mixture. 70 volumes of a solution containing 0.2 per cent v/v of ortho-phosphoric acid and 30 volumes of
methanol.
Test solution. Weigh and powder 20 tablets. Weigh a quantity of the powder containing 75 mg of Lamivudine, dissolve
in the solvent mixture and dilute to 100.0 ml with the solvent mixture, filter.
Reference solution. Weigh 75 mg of lamivudine RS, 130 mg of nevirapine RS and 20 mg of stavudine RS, dissolve in
20 ml of methanol and dilute to 100.0 ml with the solvent mixture. Dilute 1.0 ml of the solution to 100.0 ml with the
solvent mixture.
Chromatographic system
– a stainless steel column 25 cm  4.6 mm, packed with octadecylsilane bonded to porous silica (5 µm),
– mobile phase: A. methanol,
B. a buffer solution prepared by dissolving 1.925 g of ammonium acetate in 1000 ml of water and
adjusting to pH 3.0 with trifluoroacetic acid,
– flow rate: 1.2 ml per minute,
– a gradient programme using the conditions given below,
– spectrophotometer set at 266 nm,
– injection volume: 10 µl.
Time
Mobile phase A
Mobile phase B
(in min.)
(per cent v/v)
(per cent v/v)
0
5
95
15
15
85
30
45
55
40
60
40
48
60
40
51
5
95
60
5
95
Name
Carboxylic acid
Thymine
Lamivudine
Stavudine
Nevirapine
Relative
retention time
0.36
0.42
0.74
1.0
2.19
Inject the reference solution. The test is not valid unless the column efficiency is not less than 2000 theoretical plates
and tailing factor is not more than 1.5 for each component.
Inject the reference solution and the test solution. In the chromatogram obtained with the test solution, the area of any
secondary peak is not more than 3 times the area of principal peak due to lamivudine in the chromatogram obtained
with the reference solution (3.0 per cent) and the sum of areas of all the secondary peaks is not more than 5 times the
area of principal peak due to lamivudine in the chromatogram obtained with the reference solution (5.0 per cent).
Insert before Other tests.
Uniformity of content. (For tablets containing 10 mg or less of an ingredient). Comply with the test stated under
Tablets.
Determine by liquid chromatography (2.4.14) as described in the Assay using the following solution as the test
solution.
Test solution. Disperse one tablet in 20 ml of water, add 80 ml of the solvent mixture and mix with the aid of
ultrasound and dilute to 250.0 ml with the solvent mixture, filter.
Lansoprazole.
Page 1568
Related substances. Reference solution (b)
10 of 16
IPC/7035/IP-2010/AL-5
Change to: Reference solution (b). A 0.0025 per cent w/v solution of lansoprazole RS in methanol. Dilute 1.0 ml of
this solution to 10.0 ml with the solvent mixture.
Lansoprazole Capsules. Page 1570, 2925
Dissolution. Lines 13 and 14.
Change from: D. Not more than 10 per cent of the stated amount of C16H14F3N3O2S.
to: Complies with the acceptance criteria given under acid stage.
Assay. Reference solution (b).
Change to: Reference solution (b).A 0.3 per cent w/v solution of lansoprazole RS in a mixture of 3 volumes of 0.1 M
sodium hydroxide and 2 volumes of acetonitrile. To 25.0 ml of this solution, add 5.0 ml of internal standard solution
and dilute to 50.0 ml with the solvent mixture. Dilute this solution with the solvent mixture to obtain a solution
containing 0.01 per cent w/v of Lansoprazole.
Levocetrizine Hydrochloride. Page 1573
Insert before structure
Levocetrizine Dihydrochloride
Linezolid Tablets. Page 1591
Labelling. Delete the requirement.
Lithium Carbonate Tablets. Page 1596
Dissolution. Line 5,
Change from: dilute to 100.0 ml with water.
to: dilute to 100.0 ml with water. Filter and dilute with water if necessary.
Loperamide Tablets.
Page 1601
Dissolution. Lines 4 and 5
Change from: Withdraw 10 ml of the medium from each vessel, mix and filter.
Test solution. The mixed filtrate from the dissolution medium.
to: Withdraw a suitable volume of the medium and filter.
Test Solution. Use the filtrate.
Lopinavir. Page 1602
Assay. Test solution.
Change to: Test solution. Dissolve 50 mg of the substance under examination in the solvent mixture and dilute to 50.0
ml with the solvent mixture. Dilute 10.0 ml of this solution to 50.0 with the solvent mixture.
Reference solution.
Change to: Reference solution. A 0.02 per cent w/v solution of lopinavir RS in the solvent mixture.
Heavy Magnesium Oxide. Page 1623
Heavy metals.
Change to: 12 ml of solution A complies with the limit test for heavy metals, Method D (30ppm), using lead standard
solution (1ppm Pb)
Medroxyprogesterone Acetate. Page 1640
Related substances. Last para,
Change to: Inject test solutions (a) and (b). Record the chromatograms for 1.5 times the retention time of the principal
peak. In the chromatogram obtained with test solution (b) the area of any secondary peak is not more than 0.5 times the
area of the principal peak in the chromatogram obtained with test solution (a) (1.0 per cent) and the sum of the areas of
all the secondary peaks is not more than 0.75 times the area of the principal peak in the chromatogram obtained with
test solution (a) (1.5 per cent). Ignore any peak with an area less than 0.025 times the area of the principal peak in the
chromatogram obtained with test solution (a) (0.05 per cent).
11 of 16
IPC/7035/IP-2010/AL-5
Menthol. Page 1649
Related substances. Chromatographic system, line 6
Change from: column 80°
to: column 80°, after 2 minutes, increase the temperature of the column to 240° at a rate of 8° per minute and
maintain at this temperature for 15 minutes.
After chromatographic system, para 1 and 2
Change to: Inject 1 µl of each solution. Run the chromatogram obtained with the test solution for 3 times the retention
time of the principal peak. In the chromatogram obtained with the test solution the sum of the areas of all the secondary
peaks is not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (1.0 per
cent). Ignore any peak with an area less than the principal peak in the chromatogram obtained with reference solution
(b) (0.5 per cent).
Meropenem Injection.
Page 1656
Amendment list 4
Sodium carbonate. Insert
Sodium carbonate. 80 per cent to 120 per cent of the labeled amount of sodium carbonate.
Minoxidil. Page 1697
Heavy metals.
Change to: Dissolve 1.0 g in 25 ml of methanol, the solution complies with the limit test for heavy metals, Method D
(20 ppm).
Multiple Electrolyte and Dextrose Injection Type V. Page 1715
Assay.
For magnesium. Para 1, Insert at the end,
Carry out a blank titration using 17.5 mg of CaCl2.2H2O dissolved in 50 ml of distilled water, add 5.0 ml of ammoniaammonium chloride solution and dilute to 250 ml with water. Calculate the content of magnesium with the volume
obtained by subtracting the volume of EDTA required for calcium from the consumption of 0.005 M EDTA in the
titration of magnesium.
Neotame. Page 1769
Para 2, line 2
Change from: dried
to: anhydrous
Nifedipine Sustained -release Tablets. Page 1781
Dissolution. Last para,
Change to: D. Not less than 60 per cent cumulative of both the medium of the stated amount of C17H18N2O6.
Olanzapine Tablets. Page 1812
Assay. Chromatographic system, line 10
Change from: 220 nm
to: 260 nm
Omeprazole Capsules. Page 1814
Dissolution. B. Line 6 to 8
Change from: Using the filtered medium as the test solution, carry out the determination as described in the Assay.
to: Immediately transfer 5.0 ml of the solution to a test tube containing 1.0 ml of 0.1 M sodium hydroxide.
Prepare the standard solution having a known concentration similar to the expected concentration and in
similar manner to the test solution.
Ondansetron Orally Disintegrating Tablets. Page 2938
Disintegration.
12 of 16
IPC/7035/IP-2010/AL-5
Change to: Disintegration (2.5.1). Not more than 30 seconds.
Oseltamivir Phosphate. Page 1827
Loss on drying.
Change to: Water (2.3.43). Not more than 0.5 per cent, determined on 0.5 g.
Oseltamivir Capsules. Page 1828
Water. Delete the requirement.
D‐Panthenol. Page 1856
Structure change to:
H OH H
N
HO
OH
Me Me O
Paracetamol Oral Suspension. Page 2940
Related substances. After chromatographic system, para 2, lines 5 and 6
Change from: not more than the area of the corresponding peak in reference solution (b) (0.1 per cent)
to: not more than 5 times the area of the corresponding peak in reference solution (b) (0.5 per cent).
Paracetamol Syrup. Page 1860
Assay. Test solution.
Change to: Test solution. Mix an accurately weighed quantity of the preparation under examination containing 50 mg
of Paracetamol in 70 ml of the mobile phase, dilute to 100.0 ml with the mobile phase. Further dilute 5.0 ml of the
solution to 20.0 ml with the mobile phase.
Pentazocine Hydrochloride. Page 1873
Assay. Line 2,
Change from: anhydrous glacial acetic acid
to: anhydrous glacial acetic acid, add 10.0 ml of mercuric acetate solution.
Pilocarpine Eye Drops. Page 2943
pH.
Change from: 2.5 to 4.2
to: 3.0 to 5.5
Polyoxyl 35 Castor Oil. Page 1931
Heavy metals. Last line
Change from: lead standard solution (1 ppm)
to: lead standard solution (10 ppm)
Polyoxyl 40 Hydrogenated Castor Oil. Page 1931
Heavy metals. Last line
Change from: lead standard solution (1 ppm)
to: lead standard solution (10 ppm)
Psoralen. Page 2001
Assay.
13 of 16
IPC/7035/IP-2010/AL-5
Change to: Dissolve 0.1 g in sufficient methanol to produce 100.0 ml. Dilute 2.0 ml of this solution to 100.0 ml with
methanol. Further dilute 1.0 ml of this solution to 10.0 ml with methanol and measure the absorbance of the resulting
solution at the maximum at about 247 nm (2.4.7).
Calculate the content of C11H6O3 from the absorbance obtained by repeating the operation using a final solution of 2 µg
per ml of psoralen RS in methanol in place of the substance under examination.
Quinine Dihydrochloride Injection. Page 2023
Identification
A. Test solution. Line 2
Change from: Quinine Dihydrochloride Bisulphate
to: Quinine Dihydrochloride
Rabeprazole Sodium. Page 2037
Storage. Change to:
Storage. Store protected from light and moisture, at a temperature not exceeding 25º.
Ramipril and Hydrochlorothiazide Tablets. Page 2041
Related substances. Last para, last line
Insert at the end
Ignore the peak due to hydrochlorothiazide.
Uniformity of content. Change to:
Uniformity of content. Comply with the test stated under Tablets.
Determine by liquid chromatography (2.4.14), as described under Assay.
Test solution. Disperse 1 intact tablet in water and dilute to 25.0 ml with the mobile phase. Dilute 3.0 ml of this
solution to 25.0 ml with the mobile phase and mix.
Assay. Change to:
Assay. Determine by liquid chromatography (2.4.14).
Test solution. Weigh and powder 20 tablets. Weigh a quantity of powder containing about 25 mg of Ramipril, disperse
in water and dilute to 250.0 ml with the mobile phase, filter. Dilute 3.0 ml of this solution to 25.0 ml with the mobile
phase and mix.
Reference solution (a). A 0.024 per cent w/v solution of ramipril RS in the mobile phase.
Reference solution (b). A 0.06 per cent w/v solution of hydrochlorothiazide RS in the mobile phase.
Reference solution (c). Dilute reference solutions (a) and (b) with the mobile phase to obtain a solution having a known
concentration similar to the test solution.
Chromatographic system
– a stainless steel column 25 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 µm) (Such as
Thermo quest Hypersil),
– mobile phase: a mixture of 55 volumes of water, 45 volumes of acetonitrile and 0.1 volume of triethylamine,
adjusted to pH 3.0 with orthophosphoric acid,
– flow rate: 1 ml per minute,
– spectrophotometer set at 210 nm,
– injection volume: 20 µl.
Inject reference solution (c). The test is not valid unless the relative standard deviation for replicate injections for each
peak is not more than 2.0 per cent.
Inject reference solution (c) and the test solution.
Calculate the content of C23H32N2O5 and C7H8ClN3O4S2 in the tablet.
Salbutamol Sulphate. Page 2085
14 of 16
IPC/7035/IP-2010/AL-5
Related substances. Last para, line 9
Change from: 0.05 per cent
to: 0.17 times
Last line
Change from: reference solution.
to: reference solution (0.05 per cent).
Sildenafil Citrate. Page 2100
Para 1, line 3
Change from: dried basis
to: anhydrous basis
Related substances. After chromatographic system, para 1,
Change to: The relative retention time with reference to sildenafil for citric acid is about 0.11, for N-oxide is about
0.29 and for chlorosulphonyl is about 1.6.
Inject reference solution (b). The test is not valid unless the column efficiency is not less than 2000 theoretical plates
and tailing factor is not more than 2.0.
Loss on drying.
Change to: Water (2.3.43). Not more than 2.5 per cent, determined on 0.2 g.
Sodium Bicarbonate Injection. Page 2111
Bacterial endotoxins.
Change to: Bacterial endotoxins (2.2.3). Not more than 1.7 Endotoxin Units per ml.
Sorbic Acid.Page 2955
Heavy metals. Change to:
Heavy metals. 12 ml of 5 per cent w/v solution in ethanol (95 per cent) complies with the test for heavy metals,
Method D (10 ppm), using 5 ml of lead standard solution (1ppm Pb) and 5 ml of ethanol (95 per cent).
Thiopentone Sodium. Page 2216
Insert before Storage
Thiopentone sodium intended for use in the manufacture of parenteral preparations without a further appropriate
sterilization procedure complies with the following additional requirement.
Sterility (2.2.11). Complies with the test for sterility.
Tiotropium Bromide Powder for Inhalation. Page 2228
Para 1, lines 1 and 2
Change from: Tiotropium Bromide
to: Tiotropium Bromide Monohydrate
Labelling. Line 1
Change from: active ingredient
to: tiotropium
Vinorelbine Injection. Page 2304
Related substances. Change to:
Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Dilute a volume of injection containing 10 mg of Vinorelbine to 10 ml with the mobile phase.
Reference solution (a). A 0.14 per cent w/v solution of vinorelbine tartrate RS in the mobile phase.
15 of 16
IPC/7035/IP-2010/AL-5
Reference solution (b). Dilute 1.0 ml of reference solution (a) to 100.0 ml with the mobile phase.
Reference solution (c). A solution containing 0.14 per cent w/v of vinorelbine tartrate RS and 0.001 per cent w/v of
vinorelbine impurity A RS in water. Expose a portion of this solution in a suitable xenon lamp for about 1 hour, in order
to generate an additional degradation product.
Chromatographic system as described in the Assay.
The relative retention time with reference to vinorelbine for 3’,4’,7,8-tetradehydro-3,4’-dideoxy-3,6-epoxy-6,7dihydro-C’-norvincaleukoblastine (photodegradation product) is about 0.8, for vinorelbine impurity A (4-Odeacetylvinorelbine) is about 1.2.
Inject reference solutions (a) and (c). The test is not valid unless the relative retention between vinorelbine tartrate and
vinorelbine impurity A is not less than 1.1 in the chromatogram obtained with reference solution (c) and relative
standard deviation for replicate injection is not more than 2.0 in the chromatogram obtained with reference solution (a).
Inject reference solution (b) and the test solution. Run the chromatogram 3 times the retention time of the principal
peak. In the chromatogram obtained with the test solution, the area of any peak corresponding to vinorelbine impurity
A is not more than 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (b)
(0.3 per cent); the area of any peak corresponding to photodegradation product is not more than the area of the principal
peak in the chromatogram obtained with reference solution (b) (1.0 per cent); the area of any other secondary peak is
not more than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.2 per
cent) and the sum of areas of all the secondary peaks is not more than twice the area of the principal peak in the
chromatogram obtained with reference solution (b) (2.0 per cent).
Zidovudine, Lamivudine and Nevirapine Tablets. Page 2334
Dissolution. Line 3
Change from: 50 rpm
to: 75 rpm
Zinc Sulphate Dispersible Tablets. Page 2970
Identification. Solution A.
Change to: Solution A. Shake a quantity of powdered tablets containing about 5 g of Zinc Sulphate with 100 ml of
water and filter. The filtrate complies with the following tests:
B, line 1,
Change from 0.2 ml
to: 0.1 ml
Assay. Line 3
Change from: 50 mg
to: 1 g
Line 4,
Change from: xylenol orange
to: xylenol orange triturate
Line 5,
Change from: methenamine
to: hexamine
Labelling. Line 1
Change from: zinc sulphate
to: zinc sulphate monohydrate
Zinc Sulphate Oral Solution. Page 2970
Assay. Line 4
Change from: 3 ml
to: 0.3 ml
16 of 16