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Conducting Nitrosamine impurity testing and analysis on drug substance and drug product
Using mass spec analysis techniques to mitigate the risk of NDMA presence during the manufacture of medicines containing chemically synthesised active substances.
Nitrosamines are organic compounds that we are commonly exposed to. They exist in low levels in our water and foods, including meat, vegetables, and dairy products. They originate from chemical reactions and can form in drugs during manufacturing.
Nitrosamines are classified by the ICH M7(R1) Guideline as Class 1 impurities, “known mutagenic carcinogens”(1), and may increase the risk of cancer if people are exposed to them above acceptable levels over a significant time period.Download Contact us