N-Nitrosamines are a class of toxic substances that are considered probable carcinogens (potentially genotoxic impurities) for human health.
N-nitrosamines have been reported in drug products, air, water, foods, cosmetics, tobacco, and packing materials. Recently, the recall of several Angiotensin II Receptor Blocker (ARB) drugs, e.g., Valsartan, Losartan, and Irbesartan made N-Nitroso impurities a focus for regulatory agencies. Nitrosamine impurities in APIs are byproducts, produced in trace amounts during the manufacturing processes of these medicines.
ITC Labs has taken a lead in this direction to support related Industries in risk assessment due to probable sources of additives, water, process impurities, degradants etc. Our Scientists have developed several methods on different matrices, achieving lowest sensitivity for numerous Nitrosamine impurities in a single run using ultra- sensitive analytical techniques.
The methods developed and validated by ITC Labs have found wide acceptance and appreciation within the industry from the regulatory authorities of several European countries in addition to our own. ITC Labs tests for 15+ impurities on a regular basis in addition to different Nitrosamine Drug Substance Related Impurities (NDSRI) while the testing for the same number of these impurities is under development.
We also facilitate risk assessment by checking the presence of precursors of N-nitrosamine impurities.
