Impurities in Foods and Pharmaceuticals : Global Issues and Regulatory Control

ISBN-13: 9783659197277 / Angielski / Miękka / 2012 / 288 str.

Poonam Kushwaha

Opis

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.

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O autorze

Poonam Kushwaha is an associate professor in the Faculty of pharmacy at Integral University in Lucknow, India.