New nitrosamine guidelines: FDA and EMA

The FDA (Food and Drug Administration) has released the final guidelines for controlling nitrosamine impurities in pharmaceuticals, providing crucial directions for manufacturers of active pharmaceutical ingredients (APIs) and drugs.

What does the FDA guideline cover?

The new guidelines outline the main sources of impurities and recommend a risk assessment approach, specific testing, and control strategies to prevent unacceptable levels of nitrosamines.

Key points include:

• Identification of two main classes of nitrosamines: small molecule nitrosamines and nitrosamine drug substance-related impurities (NDSRIs).
• Detailed insights into the potential formation of NDSRIs and mitigation strategies.
• Recommendations for risk assessment, implementation of tests, and adoption of strategies to prevent or reduce nitrosamine impurities.

To keep pace with ongoing scientific and technical advancements, the FDA continuously updates information on acceptable intake limits (AI), analytical methods, and safety testing, available on their official website.

EMA Updates

The EMA (European Medicines Agency) has recently expanded the list of nitrosamines under monitoring and revised limits for some of them. Discover more details by clicking here!

How can we support you?

LabAnalysis offers extensive experience and state-of-the-art instrumentation to assist clients in ensuring compliance with the latest regulations and guidelines.

For more information, please contact:
sales.pharma@labanalysis.it