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Published on:10th Feb 2015
Indian Journal of Pharmaceutical Education and Research, 2010; 44(3):301-310
Review Article | doi:Nill

Pharmaceutical Impurities: An Overview


Authors and affiliation (s):

N. Rama Rao, S. S. Mani Kiran* and Prasanthi N.L.

Chalapathi Institute of Pharmaceutical Sciences, Lam, Guntur- 522034

Abstract:

The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product. The control of impurities is currently a critical issue to the pharmaceutical industry. International Conference on Harmonization (ICH) formulated guidelines regarding the control of impurities. This review outlines the description of different types and origins of impurities and degradation routes with specific examples.

Key words: Impurities, formulation, efficacy, degradation.

 




 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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