Nitrosamines are chemical substances, some of which are considered carcinogens and genotoxic agents, that can be produced in raw materials and finished drug products by the reaction of amines with nitrates or nitrites with Active Pharmaceutical Ingredients (APIs) and excipients of drug products. Nitrosamine Drug Substance-Related Impurities (NDSRIs) were first recognized as a human health risk by the US FDA in 2018.
Scientech Laboratories has advanced LC-MS and GC-MS instruments to identify and quantify NDSRIs.
In September of 2024 the US FDA released updated guidance for the Control of Nitrosamine Impurities in Human Drugs which identified sources, causes, means of testing, control, and mitigation of nitrosamines in Active Pharmaceutical Ingredients and drug products. Analytical testing for small molecule nitrosamines and NDSRIs in APIs and drug products is essential to identifying risk, evaluating mitigation measures, and determining the safety of finished products.
Scientech Laboratories has advanced LC-MS and GC-MS instruments to identify and quantify NDSRIs. Triple quadruple mass spectrometry (LC-MS/MS) instruments can quantify NDSRI levels to sub-ppb levels to provide accurate and sensitive risk assessment of your API or drug product.
cGMP compliant
FDA registered
DEA licensed
Documentation
107 Corporate Blvd,
Suite G
South Plainfield, New Jersey 07080
©scientech-labs.com
