System Suitability and Validation for Chiral Purity Assays of Drug Substances
November 1st 2006Measurement 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
July 1st 2005The 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.