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Physicochemical Properties

Determination of physicochemical properties according to ICH Q6B guidelines

Alphalyse offers a range of analytical services for determination of Physicochemical Properties. They have been designed according to appendix 6.1.2 in the ICH Q6B guidelines Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

 

You can choose between following services

Molecular weight by UV-LC ESI-MS  >
We determine the exact mw of proteins present in your drug sample.

Extinction coefficient  >
UV-spectrophotometry (A280) determination of the extinction coefficient of your drug substance protein.

1d and 2d gel electrophoresis  >
We determine the electrophoretic pattern of your drug sample by 1D or 2D SDS PAGE separation.

Liquid chromatographic pattern  >
We use UV-HPLC separation to determine the liquid chromatographic pattern of your drug sample.

 

Send us your project description & we design a service package meeting your needs


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