White Paper: A Review on Nitrosamines
Published September 2022
Abstract:
Nitrosamines are organic compounds that exist at low levels in our water, food, and small-molecule pharmaceuticals. Most nitrosamines are identified as part of a group of high-potency mutagenic carcinogens referred to as the “cohort of concern.” The recent discovery of nitrosamines in commonly prescribed pharmaceuticals has led to an increase in regulatory and industry guidance in manufacturing processes.
This white paper explores:
- Potential and Confirmed Root Causes for The Presence of Nitrosamines in Drug Products
- Factors to Examine When Determining the Priorities and Order in Which Pharmaceuticals Should Be Assessed
- Global Regulations (EMA, FDA, HC)
- What Can Manufacturers Do to Mitigate Nitrosamine Formation?
- The Latest Nitrosamine News
Keywords: nitrosamines, NDMA, chemical impurities, contaminants, API manufacturing, finished product manufacturing, API intermediates, drug product packaging and storage, nitrosamine mitigation, organic compounds, mutagenic carcinogens, GMP, FDA, Health Canada, EMA
Click here to view White paper: A Review on Nitrosamines