Der Pharmacia Lettre

Abstract

Genotoxic impurities Evaluation in Active Pharmaceutical Ingredients (API)/ Drug Substance

Author(s): Madhuresh K. Sethi, Rusha Guha, Rohit Shukla, Sanjay Mahajan, Purbita Chakraborty and Anil Thakan

The main areas discussed in this review are evaluation of control strategies of genotoxic impurities at different levels in the manufacturing of active pharmaceutical ingredients. The acceptable levels and control strategies of various guidelines are evaluated in detail.

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