Impurity profiling an emerging trend in Pharmaceuticals: A Review
Abstract
Impurity profiling brings tremendous efforts in the group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. The control of impurities is currently a critical issue to the healthcare manufacturing. Various regulatory authorities like ICH, USFDA, UK-MHRA, CDSCO are emphasizing on the requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s) and as well as finished products. International Conference on Harmonization (ICH) formulated guidelines concerning the control and limit of impurities. To isolate and characterize impurities in pharmaceuticals diverse methods are used such as, capillary electrophoresis, gas–liquid chromatography, high performance liquid chromatography, solid-phase extraction methods, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction chromatography, mass spectroscopy, Nuclear magnetic resonance (NMR) spectroscopy etc. On the beginning of hyphenated techniques, the most browbeaten techniques for impurity profiling are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LCNMR, LC-NMR-MS, GC-MS and fully automated Comprehensive Orthogonal Method Evaluation Technology (COMET). That is why it has plentiful claim in the field of drug design, monitoring quality, stability and as well as safety of the product.
References
2. Guidance for Industry, ANDAs: Impurities in Drug Substances, U.S. Department of Health and HumanServices, Food and Drug Administration, Centre for Drug Evaluation and Research, January 2005(fda.gov/cder/guidance/6422dft.htm).
3. International Conferences on Harmonization, Draft revised Guidance on Impurities in new drug substances Q3A(R2)., 25 October 2006
4. U.S. Food and Drug Administration. Guidance for Industry, Q3A Impurities in New Drug Substances. February 2003.
5. Ahuja Satinder. Impurities Evaluation of Pharmaceuticals. Ed., New York; Marcel Dekker. 1998; 15-18.
6. Parimoo P. A Text Book of Pharmaceutical Analysis, CBS publishers and distributors, NewDelhi. 1998; 20-21.
7. S. J. Ingale et al. Advance approaches for the impurity profiling of pharmaceutical drugs: A review. Int. J. of Pharm. & Life Sci 2011;2(7);955-962.
8. Pradeep Patil, Dr. Vaidya. Overview on Impurity Profiling. Int. J. For Pharm Res Sch.,2013;2(2):54-65.
9. Roy J. Pharmaceutical impurities-A mini review. AAPS Pharm Sic Tech 2002;3(2);1-11.
10. The Nature and Origin of the Impurities in Drug Substances (1.2), Sdndor Ggrgg Chapter 1. 1998;12-13.
11. Residual Solvents, Q3C. Federal Register, 62(247), 2000; 67377.
