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In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products.
By Kashyap R. Wadekar, Mitali Bhalme, S. Srinivasa Rao, K. Vigneshwar Reddy, L. Sampath Kumar and E. Balasubrahmanyam
To ensure the quality of APIs and finished drug products, impurities must be monitored carefully during process development, optimization, and process changeover. The isolation, characterization, and control of impurities in pharmaceutical substances are being reviewed with greater attention based on national regulatory and international guidelines. In Part I of this article, the authors examine the different types and sources of impurities with specific examples.
This article was also published in our US sister publication Pharmaceutical Technology and can be read here.