USA – FDA suggests alternative approaches for nitrosamine risk assessments

The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug products to inhibit the formation of nitrosamine impurities.

These approaches were outlined in recent update on possible mitigation strategies to reduce the risk of nitrosamine impurities in drug products. The update was prompted by reports of certain types of nitrosamine impurities that formed in “several drug products.”

FDA said that “nitrite impurities have been observed in a range of commonly used excipients (as well as water) and may lead to the formation of NDSRIs [nitrosamine drug-substance-related impurities] in certain drug products.”

The update is meant to complement FDA’s guidance in September 2020 on controlling the risk of nitrosamine in drug products. (RELATED: N-Nitrosamine impurities: FDA issues detection, prevention guidance, Regulatory Focus 1 September 2020)…