Pharmaceutical impurities--a mini-review.
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.
Roy
Jiben
J
Department of Bioscience, Salem International University, Salem, WV 26426, USA. roy@salemiu.edu
D004340:Drug Contamination / Q000517:prevention & control; D004355:Drug Stability