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By Candice Sun

December 17, 2020

Technical Guideline for Study of Nitrosamine Impurities in Chemical Drugs (Trial) was issued by the China National Medical Products Administration on 8 May 2020. This guideline discusses nitrosamine impurities in drug products, including the sources of nitrosamine impurities and the control strategy. The control strategy is given from the perspectives of the basic concept of control, control limits, establishment of analytical methods, and control of risk throughout the drug product lifecycle.