In July 2018 Health Canada first became aware of the presence of nitrosamine impurity, N-nitrosodimethylamine (NDMA) in certain “sartan” angiotensin receptor blocker (ARB) blood pressure medications and has been working to address the issue. Similar nitrosamine impurities were subsequently found in other medications. Health Canada has requested manufacturer to test their products if a risk of nitrosamines is identified.
Neopharm Labs can help you!
Why Choose Neopharm Labs?
The low levels at which the nitrosamine impurities occur creates challenges for testing. Ultra-low levels of these molecules must be quantified in complex matrices. The developed methods then need to be validated to conform to GMP requirements.
Neopharm is certified GMP by Health Canada and FDA
Neopharm is equipped with LC/MS/MS
Neopharm is globally known as an expert in nitrosamine testing at the ppb level, including validating methods for several products (sartans and ranitidine, metformin, etc.).
Neopharm Labs is already assisting many clients in validating methods with the lowest possible LOD/LOQ.