Establishing Acceptance Criteria for Approved Impurities in Drug Manufacturing

Abstract

In the pharmaceutical industry an impurity is defined and recognized the any other organic material besides the drug substance or pharmaceutical ingredients. This paper includes the ongoing impurities in drug development, particularly the API related impurities, for example, degradation related impurities (DRIs) and interaction related impurities (IRIs), may adversely affect the quality, safety, and efficiency of drug products. It is essential that the requirements of regulatory and management strategies are determined. Sources of impurities must also be carefully classified prior to taking subsequent steps, such as developing analytical methods and acceptance criteria. The various international regulatory criteria and requirements are reviewed to bring out the more modifies impurity management outlines. Scheme for the establishment of analytical methods and acceptance criteria of PRIs and DRIs in accordance with the requirements of International Council for Harmonization (ICH) and algorithm to perform the recognition of DPIs by using LC-MS/MS has been proposed.