Pharmaceuticals impurities are the unwanted chemicals that are either generated during the formulation of the dosage form or are present during the initial synthesis. Thus the control of pharmaceutical impurities is currently a very critical issue to the pharmaceutical industry. The International Conference on Harmonization has formulated a workable guideline to control the impurities of the pharmaceuticals. Impurity profiling helps in the detection, identification and quantification of various types of impurities as well as residual solvents present in bulk drugs as well as in pharmaceutical formulation is done with the help of impurity profiling. Identification of the presence of impurities below 0.1% level is not considered to be important as per the ICH guidelines on impurities in new drug product unless the potential impurities are expected to be unusually potent or toxic. However in all cases, impurities should be qualified as it is the best way to characterize quality and stability of bulk drugs and pharmaceutical formulations. It is imperative to review problems related to impurities present in the drug substances and drug products with their solutions due to rapid development of the analytical methodology. Thus enlightening the need of impurity profiling of drug substances in pharmaceutical research this review focuses on various analytical methods for identification as well as quantification of impurities present in the pharmaceuticals.
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