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N-Nitroso N-Methyl 4-amino butyric acid (NMBA)
Uses:
- generated during the manufacturing process of losartan
Adverse effects:
- known animal carcinomgen & potential human carcinogen
Notes:
- found in loartan-containing products. [1]
General
carboxylate
toxin (hazardous material, poison)
Database Correlations
PUBCHEM cid=5921
References
- FDA News Release. March 1, 2019
FDA provides update on its ongoing investigation into ARB drug
products; reports on finding of a new nitrosamine impurity in
certain lots of losartan and product recall.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632425.htm
- FDA Safety Alert. Feb 28, 2019
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall
of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg
Due to the Detection of Trace Amounts of N-Nitroso N-Methyl
4-amino butyric acid (NMBA) Impurity found in the Active
Pharmaceutical Ingredient (API).
https://www.fda.gov/Safety/Recalls/ucm632395.htm