Nitrosamines Impurities Remediation
Nitrosamines Impurities Risk Assessment & Remediation
N
itrosamines are produced in the reaction of nitrites and secondary amines. In 2018, angiotensin II receptor blockers (ARB) medicines were withdrawn from the market in the US due to the presence of an impurity, N-nitrosodimethylamine (NDMA). Since then, regulatory agencies and pharmaceutical companies around the world have an increased focus on the potential for nitrosamine impurity growth in marketed drug products.
In 2021, FDA released its guidance document “Control of Nitrosamine Impurities in Human Drugs” to help companies reduce the levels of nitrosamine impurities in their drug products and ultimately achieve compliance to tightening US and global standards. Solving nitrosamine impurity challenges requires a multidisciplinary approach understanding API manufacturing technology, analytical chemistry, toxicology, formulation technology, and manufacturing processes technology. As a multidisciplinary, end-to-end R&D service company, Vici Health Sciences is well positioned to solve your nitrosamine impurity problems both during development and post-commercialization.
At Vici Health Sciences, we help you with:
- Risk assessment
- Performing root cause analysis to determine source of nitrosamine contamination
- Work with API vendors to reduce nitrite contamination (which leads to nitrosamine contamination)
- Test nitrite levels in intermediate, API, and drug product samples as part of risk assessment and root cause analysis
- Coordinate testing for nitrosamine contaminants in qualified external labs
- Perform stability studies to track growth of nitrosamine impurities and establish specifications and shelf life
- Remediate nitrosamine impurity specification failures through re-formulation or manufacturing process modification of your product in R&D scale or at commercial scale
- Provide strategic regulatory consultation and work with the FDA as part of the broader nitrosamine mitigation strategy for your product
- Ensure that all aspects of the supply chain and regulatory compliance are coordinated to make sure that your product gets to the market fast and stays in the market
We help companies handle and manage nitrosamine-related projects and meet Agency mandated deadlines. Contact us to discuss your options for nitrosamine-related impurities.
