CORE COMPONENTS OF ANALYTICAL METHOD VALIDATION FOR SMALL MOLECULES: AN OVERVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 5
Abstract
Analytical methods development and validation play significant roles in the drug discovery, development, manufacture of pharmaceuticals and estimation of small molecules. The official test methods that result from these processes are used by quality control laboratories to ensure the accuracy, precision, selectivity, sensitivity, reproducibility, stability, and performance of drug products. This muster gives a review and the information about various stages involved in development and validation of analytical methods for small molecules with emphasis on chromatographic techniques, a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation as per ICH guide lines.
Authors and Affiliations
Subhash Chandra Kotte, P. K Dubey, P. M. Murali
Keywords
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