Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Dec 18, 2015
I – Section General Customer Information
Company:
Date:
Department.
Contact person
:
Address:
Phone Number:
Fax Number:
Company E-mail Address:
Address of account
department (if different):
II – Section General Sample Information
Sample name:
Batch/Lot:
If necessary :
PO / Cost location:
III –Kind of sample and specification



Drug product
Drug substance / API
Others
Analysis in duplicate is required
Expanded report is recommended
Substance specific validation may be necessary
Analysis in duplicate may be required
Expanded report is recommended for not substance specific validated methods
Substance specific validation may be necessary (depends on the status of the studies
and submission)
as required eg. Research and Development
Spezification
Page 1 of 9
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Dec 18, 2015
Section IV – Determination of enantiomeric purity
Chiral GC-FID for amino acids and Amino acid derivatives in
duplicate
GC-FID (A430/A440)
Chiral GC-FID for resin bond amino acid in duplicate
GC-FID (A450)
Chiral GC-MS for amino acid derivatives and peptides
GC-MS (A790)
Chiral HPLC for some amino acid derivatives
HPLC-UV (A525)
2.
Analysis in duplicate (for GC-MS or HPLC)
YES
3.
Expanded report (available for GC-MS analysis)?
YES (A987)
4.
Nominal sequence (if not elucidated by sample name)
respectively the amino acids that are to be determined.
5.
Protective groups (if not elucidated by the sequence)
6.
Counter ion (if not elucidated by the sequence)
7.
Resin (if not elucidated by the sequence)
8.
Expected concentration of the peptide / amino acid
9.
Substance specific SOP nr.
10.
Urgent analysis (30% surcharge)
1.
YES
If YES, acid cleavage possible
% or
YES
NO
mmol/g
YES
Section IVa – Additional service: Clean up
1.
Development of a method for cleanup via Microcolumns (SPE)
YES (A820)
2.
Clean up
YES (A821)
Section IVb – Additional service: Expanded SST
1.
6 injection of standard amino acids: Resolution, tail factor
YES (A797)
Section IVc – Additional service: Determination of amino acids as contaminatants
1.
Qualitative determination of other amino acids
(as aditional service only)
YES (A445)
2.
Quantitative determination of other amino acids
(as aditional service only)
YES (A470)
3.
Most reliable quantitative determination of contaminant amino
acids via GC-MS ; STANDARD
YES (A785/A786)
Page 2 of 9
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Dec 18, 2015
Section V – Quantitative Amino Acid Analyses
1.
Determination of the amino acids including determination of
blind values. Most accurate. (For GMP products etc.)
YES (A400/A401)
2.
Determination of the amino acids without determination of blind
values. Errors might happen when blind values are present.
YES (A420/A421)
3.
Determination of the amino acids including determination of
blind values. GC-MS. Most accurate for low peptide content.
YES (A770/A771)
4.
Amino acid loading on resin incl.blind values.
YES (A460)
5.
Amino acid loading on resin without blind values.
YES (A455)
6.
Analysis in duplicate ?
YES
7.
Peptide content (as aditional service only)
YES (A402)
8.
Expanded report
YES (A987)
9.
Nominal sequence (if not elucidated by sample name)
10.
Protective groups (if not elucidated by the sequence)
11.
Counter ion (if not elucidated by the sequence)
12.
Molecular weight
13.
Resin (if not elucidated by the sequence)
14.
Expected concentration
15.
Substance specific SOP nr.
16.
Urgent analysis (30% surcharge)
YES
If YES, acid cleavage possible
% or
YES
NO
mmol/g
YES
Section Va – Additional service: Clean up
1.
Development of a method for cleanup via Microcolumns (SPE)
YES (A820)
2.
Clean up
YES (A821)
Section Vb – Additional service: Expanded SST
1.
6 injection of standard amino acids: Resolution, tail factor
YES (A797)
Section Vc – Additional service: Determination of amino acids as contaminatants
1.
Most reliable quantitative determination of contaminant amino
acids via GC-MS.
Page 3 of 9
YES (A785/A786)
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Section VI – Determination of identity, content and purity by HPLC
1.
Determination of content and identity
YES (A520)
2.
SST Determination of reproducibility of retention time and area
YES (A526)
3.
Determination of purity
YES (A510)
3.
Expanded report
YES (A984)
5.
Nominal sequence (if not elucidated by sample name)
6.
Protective groups (if not elucidated by the sequence)
7.
Counter ion (if not elucidated by the sequence)
8.
Nominal molecular weight
8.
Substance specific SOP nr.
9.
Urgent analysis (30% surcharge)
YES
Section VIa – Additional service: Expanded SST
1.
6 injection of standard: Resolution, tail factor
YES (A526)
Page 4 of 9
Dec 18, 2015
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Dec 18, 2015
Section VII – Determination of molecular weight and Sequencing by MS^n
1.
Determination of molecular weight of peptides (identity)
YES (A810)
2.
Determination of Molecular weight of HPLC peaks
Chromatogram attached. RT’s of the peaks of interest:
3.
Expanded report?
YES (A985)
4.
Sequencing
YES (A805/A806)
5.
Nominal sequence (if not elucidated by sample name)
6.
Protective groups (if not elucidated by the sequence)
7.
Counter ion (if not elucidated by the sequence)
8.
Nominal molecular weight
8.
Substance specific SOP nr.
9.
Urgent analysis (30% surcharge)
(A801/A802)
YES
Section VIIa – Additional service: for cyclic peptides
1.
Determination of the molecular weight before disulfide cleavage
YES (A810)
2.
Determination of the molecular weight before disulfide cleavage
YES (A811)
Page 5 of 9
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Dec 18, 2015
Section VIII – Quantitative determination of counter ions via GC
1.
Determination of acetate in duplicate
YES (A210)
2.
Determination of trifluoro acetate in duplicate
YES (A211)
3.
Expanded report
YES (A985)
4.
Substance specific SOP nr.
5.
Urgent analysis (30% surcharge)
YES
Section IX – Quantitative determination of counter ions via Ion Chromatography
1.
Determination of acetate in duplicate
YES (A213/A214)
2.
Determination of trifluoro acetate in duplicate
YES
3.
Determination of chloride in duplicate
YES
4.
Determination of fluoride in duplicate
YES
5.
Determination of phosphat in duplicate
YES
6.
Request for other anion in duplicate
7.
Expanded report
8.
Substance specific SOP nr.
9.
Urgent analysis (30% surcharge)
YES (985)
YES
Section IXa – Additional service: Expanded SST
1.
6 injection of standard: Resolution, tail factor
YES (A215)
Page 6 of 9
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Section X – Quantitative determination of water
1.
Determination of water
YES (A200)
2.
Analysis in duplicate
YES
3.
Expanded report
YES (A985)
3.
Substance specific SOP nr.
4.
Urgent analysis (30% surcharge)
YES
Section Xa – Additional service: Expanded SST
1.
6 injection of standard: Resolution, tail factor
YES (A527)
Page 7 of 9
Dec 18, 2015
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Dec 18, 2015
Section XI – Quantitative determination of residual of solvents
1.
Determination of residual of solvents
YES (A.229/A230/A231/A232)
2.
Analysis in duplicate
YES
3.
Expanded report?
YES (A988)
4.
Substance specific SOP nr.
5.
Blank before and after analysis
YES (A228)
6.
Solvent screening
YES (A235)
7.
Expanded solvent screening
YES (A236)
8.
Substance specific SOP nr.
9.
Urgent analysis (30% surcharge)
Acetone
Acetonitrile
Anisole (B)
Allylisocyanate (not fully validated)
Benzene
Benzylalcohol (B, not fully validated)
n-Butanol
2-Butanol
Butylacetate
Chloroform
Cyclohexane
Dichloromethane
Diethylamine
Diethylether
Diisopropylamine
Diisopropylether
Diisopropylethylamine
Dimethylacetamide (B)
Dimethylformamide
Dimethylsulfoxide (B)
Dioxane (B)
Ethanol
Ethylacetate
Heptan
n-Hexane
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
Isohexane (I, II, III)
Isopropanol
Isopropylacetate
Methanol
Methylethylketone
n-Methylmorpholine
n-Methylpyrrolidone
2-Methyltetrahydrofurane
1-Octanol
Pentane
Phenol
Piperazine (not fully validated)
Piperidine
4-Piperidinol (B)
Pyridine
t-Butanol
T-Butyl-Methylether
Tetrahydrofurane
Thioanisole
Toluene
Triethylamine
Xylene (I, II, III)
Triethylsilane
Triisopropylsilane (B)
Other:
Page 8 of 9
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
Order Form
C.A.T. GMBH & CO
CHROMATOGRAPHIE UND
ANALYSENTECHNIK KG.
HEERWEG 10, D-72070 TÜBINGEN
Revision Number
Dec 18, 2015
Required sample amounts:
We need the followings sample amounts plus some additional amount for sample handling.
AAA
Enantiomerlabeling
min 3mg, better 5mg
without determination of blind values
min 1mg, better 3mg
other amino acids
min. 2mg, better 5mg
AcOH / TFA – content
min. 3mg, better 5mg
Enantiomeric purity of amino acid derivatives
min 2mg, better 5mg
Enantiomeric purity of peptides (GC-MS)
min 1mg, better 5mg
(depends on the length of peptide)
Residuals of solvents
min 3mg, better 5mg
For analyses in duplicate the required sample amount is double.
The amount needed for sample handling depends on the physical properties. A freeze dried
product needs nearly no additional amount whereas an oily product some 10mg’s.
These amounts are necessary to obtain the required accuracy of the weighing process (minimum
weight in accordance to USP) and the required LOQ’s.
Please ask if these sample amounts are not available.
Shipment:
Shipment is possible by any carrier (FEDEX, DHL, TNT…..)
Temperature
It depends on the regulation of the customer if temperature control is necessary..
Container
Any container is possible (Eppendorf tubes, Screw cap vials, ….)
For shipment from outside EU
To avoid additional charges please take care that the proforma invoice is < 20US$.
Otherwise additional custom fees will be charged. In addition shipments <20US$ usually
would pass the custom without delay.
Shipment of certificate of analysis
Certificate of analysis is faxed after finalization of the analysis.
Original Certificates of Analyses together with the raw data and the invoice will be sent by
airmail.
For US orders > 300 Euro shipment is proceeded by FEDEX international priority service.
If FEDEX shipment should be done also for orders <300 Euro or to any European country
please provide us with your FEDEX account number for freight collect.
We will do our best that you receive the results as soon as possible.
We would be please if we could serve you. Thank you for cooperation.
Please feel free to delete any unnecessary section in exception of I. II. and
III.
Page 9 of 9