Article

AAPS PharmSciTech

, Volume 3, Issue 2, pp 1-8

First online:

Pharmaceutical impurities—A mini-review

  • Jiben RoyAffiliated withDepartment of Bioscience, Salem International University Email author 

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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. The article further discusses measures regarding the control of impurities in pharmaceuticals

Key words

Bulk drugs impurities formulation drug stability degradation