Nitrosamine
Auriga Labs provide Genotoxin Nitrosamine Testing and Analysis in Pharmaceuticals
Nitrosamine testing lab services are in demand ever since the prescription pharmaceutical drug ranitidine and subsequently may rugs likemetformin, sartansetc have been in the news fornitrosaminecontamination.
Ranitidine is used for the treatment and prevention of ulcers in the stomach and intestines and for gastroesophageal reflux disease. However, the discovery of genotoxic impurity N-nitrosodimethylamine (NDMA) at low levels in some medicines, including Zantac has led to some concern among pharmaceutical manufacturers.
The nitrosamine impurity NDMA is classified as a probable human carcinogen and is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. After the discovery of NDMA by USFDA, the Drug Controller General of India has also written to state drug controllers, asking them to draw samples of ranitidine API (active pharmaceutical ingredient) from major manufacturers as well as fast-running product formulations of ranitidine and send those to Central Drug Laboratory (CDL) in Kolkata to test for the impurity.
However, all pharmaceutical testing laboratories do not have the necessary equipment or the technicians to conduct the specific testing to analyse the levels of NDMA and other nitrosamines as they are mostly present only at ppm levels. Genotoxins at any level are considered unsafe and therefore there is a need to detect their presence as they can cause adverse health effects.
