Drugs

Drug Nitrosamine Impurity Control Guidance

FDA has published a guidance, Control of Nitrosamine Impurities in Human Drugs, to recommend steps that manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The document also describes conditions that may introduce nitrosamine impurities. It revises a 2/2023 guidance by adding a section describing nitrosamine drug substance-related impurities, potential root causes of such impurities, and mitigation strategies to prevent or reduce their presence.

The guidance describes two general structural classes of nitrosamine impurities: small-molecule nitrosamine impurities and nitrosamine drug substance-related impurities that share structural similarity to the API and are generally unique to each API.

The guidance recommendations apply to all chemically synthesized APIs, drug products containing chemically synthesized APIs or fragments (including biological products containing synthesized fragments), drug products at risk due to other factors described in the guidance, and semisynthetic and fermentation products that are at risk due to their structures, similar to chemically synthesized APIs.

The guidance includes an Introduction, Background, Nitrosamine Impurities and Root Causes of Formation, Recommendations for Control and Mitigation of Nitrosamines in APIs and Drug Products, Implementation of Recommended AI Limits, Maintaining the Drug Supply, References, and three Appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome