PHARMACEUTICAL IMPURITIES AND THEIR CHARACTERIZATION: A REVIEW

S. V. Saibaba*, M. Sathish Kumar and B. Ramu

ABSTRACT

The control of pharmaceutical impurities is currently a critical issue to the pharmaceutical industry. The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities. In this review, a description of different types and origins of impurities in relation to ICH guidelines and, degradation routes, including specific examples, are presented. A well accepted fact is that some impurities are unavoidable and will be present in trace amounts hence ICH comes into picture and through its guidelines and policies establishes the specification limits, evaluation and control of impurities. The regulatory bodies and drug development authorities look up to these guidelines for launching a quality drug into the market. Validation of analytical process for impurity identification is performed to establish the impurity profile of any drug substance. Hence the major focus of this review article is on characterization of impurities, its sources, establishment of impurity profile and analytical approaches to establish its profile. The article further discusses measures regarding the control of impurities.

Keywords: Impurities, International Conference on Harmonization, Formulation, Profiling, Isolation.