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.
R. Pakula
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Articles by R. Pakula
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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Key Factors in Sample Diluent Selection for HPLC Assays of Active Pharmaceutical IngredientsPublished: July 1st 2005 | Updated:
System Suitability and Validation for Chiral Purity Assays of Drug SubstancesPublished: November 1st 2006 | Updated:
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