R. Pakula

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.

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.