C.A.T. GmbH & Co. Chromatographie und Analysentechnik KG

Heerweg 10
D-72070 Tübingen
Germany

Phone: +49 (0) 7071 / 78323
Fax: +49 (0) 7071 / 75163

General E-Mail:
info@cat-online.com

General Information > Sample amounts

 

Sample amounts

Required sample amounts:

The following amounts of sample plus an additional amount for sample handling are required.

AAA

 

At least 3mg, better 5mg

At least 1mg, better 3mg

100µg in 100µl

AcOH / TFA - content

At least 3mg, better 5mg

Enantiomeric purity of amino acid derivatives

At least 2mg, better 5mg

Enantiomeric purity of peptides (GC-MS)

At least 1mg, better 5mg
(depends on the length of peptide)

Residuals of solvents

At least 3mg, better 5mg

 

 

For analyses in duplicate, double the above amounts are required

The amount needed for sample handling depends on the physical properties of the sample. A freeze dried product needs practically no additional amount whereas an oily product will require more than 10mg’s. 

These amounts are necessary in order to obtain the required accuracy of the weighing process (minimum weight in accordance to USP) and the required LOQ’s.

Please enquire if these sample amounts are not available.

for the analysis of AAA:

the error of sample weight is higher and in consequence the error of peptide content. If the peptide content of a solution or in a vial is to determine the amount of peptide can be lower due to the fact that the sample weight is high (in case of a solution) respectively the peptide weight is not needed (for determination of the content of a vial only nominal weight is needed).

for the analysis of enantiomeric purity:

the LOQ for the enantiomers will increase, especially for Cys, Met, Trp and His.

for the analysis of residuals of solvents, moisture and counter ions:

the error of sample weight is higher and in consequence the LOQ will increase. In addition discrimination of low boiling components before analysis is possible.

in the case of OOS

Additional investigations in the case of OOS are not possible with low amount of sample.

If you have any questions please contact us.
We would be please if we could serve you and thank you for the trust you have placed in our company.

regularly inspected by FDA and German Authorities


GMP approved

Q7

ICH

USP