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R. Pakula

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Articles

System Suitability and Validation for Chiral Purity Assays of Drug Substances

System Suitability and Validation for Chiral Purity Assays of Drug Substances

I. Chion;R. Pakula;D.W. Weissmueller;Paul Wrezel
November 1st 2006

Measurement of chiral purity is a necessary means of quality control for drug substances that exhibit chiral centers. This article describes a simple and practical approach to setting up system suitability and validation for chiral purity assays.

Key Factors in Sample Diluent Selection for HPLC Assays of Active Pharmaceutical Ingredients

Key Factors in Sample Diluent Selection for HPLC Assays of Active Pharmaceutical Ingredients

I. Chion;R. Pakula;Paul Wrezel
July 1st 2005

The authors explain why sample diluent is more than just a solubilizing agent and describe a systematic process for diluent selection when developing an HPLC assay of an active pharmaceeutical ingredient.

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