Chromak Research performs testing or analysis for your products to measure Nitrosamine impurities with low detection level recommended by the FDA. Our team of experts develop methods by using various instrumentation like HPLC, GC, LC-MS, GC-MS to determine the amount of Nitroso impurities. The experienced team at Chromak Research can also develop and validate a product-specific method in order to monitor one or more targeted compounds. We can perform impurity identification and testing in accordance with FDA and ICH guidelines.
Nitrosamines are compounds with a nitroso group and amine bonded together. Nitrosamines are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state. Nitrosamine impurities are probable human carcinogens. FDA has released this document because of In July 2018, when authorities announced a recall of angiotensin II receptor blocker (ARB) medicines, known as “sartans”, due to being a probable human carcinogen N-nitrosodimethylamine (NDMA). After that incident, Nitrosamine impurities came in limelight.