PHARMACEUTICAL IMPURITIES AND DEVELOPMENT OF STABILITY INDICATING METHOD (SIM)

Sonali P. Mahaparale* and Bhakti R. Desai

ABSTRACT

There is an ever-increasing interest in impurities which are present in APIs. The presence of impurities in active pharmaceutical ingredients can have a significant impact on the quality, safety & efficacy of pharmaceuticals. Ef-forts should be made to identify, determine and characterize all unknown impurities in the drug, due to the increas-ing demand of regulatory agencies to manufacture and develop high-purity drugs. Drug impurity profiling, i.e. iden-tification, structure elucidation and quantitative determination of impurities, degradation products in bulk drug mate-rials is one of the most important fields of activities in pharmaceutical analysis and manufacturing. The degradation products may be provided through forced degradation studies, which enable development of indicators of stability methods with appropriate specificity and selectivity, provides information about possible degradation routes of a certain product, evaluation of the factors that may interfere in any way in the drug stability and critical analysis of the drug degradation profile. In this review, overview of forced degradation studies and description of different types and origins of impurities in relation to ICH guidelines, degradation routes including specific examples are presented. Also, discusses the current trends related to performance of forced degradation studies by providing a strategy for conducting studies on method development and on degradation mechanisms which is helpful for development of stability indicating method (i.e. SIAM).

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