Nitrosamines: Current Regulatory Aspects and Analytical Challenges

Management and control of Nitrosamines in pharmaceuticals is a matter of great concern and is an important part of drug development and regulatory assessment.

Current regulations and guidelines demand a comprehensive understanding of Mutagenic impurities & Nitrosamines in pharmaceutical products as they are probable human carcinogens.

This Sunday, 25th Jun 2023, from 10:00 am to 2:00 pm (IST), a LIVE workshop will be conducted by Mr. Bhaskar Napte from India to provide practical guidance as to how Mutagenic & Nitrosamine impurities can be detected & controlled in pharmaceuticals as well as the current Regulatory status.

Date & Time: 25th Jun 2023, from 10:00 am to 2:00 pm (IST)
Learning Objectives:

  • What are Nitrosamines impurities
  • Potential Source of Nitrosamines impurities
  • How to Assess Risk (3-step process) & Control Strategy
  • Analytical Method Development- How to Decide AI & Limit
  • Current Regulatory Aspect (EMA, FDA, ANVISA, Swiss Medic, Health Canada)

Free Workshop Registration link:

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