AAPS PharmSciTech

, Volume 3, Issue 2, pp 1–8

Pharmaceutical impurities—A mini-review


DOI: 10.1208/pt030206

Cite this article as:
Roy, J. AAPS PharmSciTech (2002) 3: 1. doi:10.1208/pt030206


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 drugsimpuritiesformulationdrug stabilitydegradation

Copyright information

© American Association of Pharmaceutical Scientists 2002

Authors and Affiliations

  1. 1.Department of BioscienceSalem International UniversitySalem