A Review on Multi Approaches for Impurity Isolation and its Characterization

摘要

International Conference on Harmonization (ICH) has formulated different guideline regarding the control of impurities. In this review, the impurity sources, classification, isolation, detection and characterization methods are described. The some impurities are unavoidable and will be present in trace amounts hence ICH guidelines frame the different policies and establish the specification limits, isolation and characterization is necessary for evaluation and control of impurities. The other 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 isolation and characterization of impurities using various technics, sources and classifications, establishment of impurity profile and analytical approaches to establish its profile. We also could apply the QbD to providing statistical documentary evidences.