Journal of pharmaceutical and biomedical analysis
The most recent articles from:
J Pharm Biomed Anal
-
J Pharm Biomed Anal · Feb 2019
ReviewNDMA impurity in valsartan and other pharmaceutical products: Analytical methods for the determination of N-nitrosamines.
Batch recalls for valsartan containing pharmaceutical products in July 2018 initiated a discussion on possible contaminations with N-nitrosodimethylamine (NDMA). It appeared that NDMA was generated during synthesis of the active pharmaceutical ingredient (API) from the solvent dimethylformamide (DMF) and the reagent nitrite. Discussion on NDMA as API impurity is extended to other drugs since then. ⋯ However, current availability of this combination is very limited. Alternatively, LC-MS/MS is also performed in NA analysis. An integration of a general test in future pharmacopoeias is suggested due to the toxicological relevance and broader spectrum of possible APIs that may be affected.