A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metformin

A private testing laboratory reported in a Citizen Petition (CP) to FDA that 16 of 38 metformin drug products they tested had N-nitrosodimethyl amine (NDMA) amounts above the allowable intake (AI) of 96 ng/day. Because the FDA had been monitoring drugs for nitrosamines, orthogonal analytical procedu...

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Detalles Bibliográficos
Autores principales: Yang, Jingyue, Marzan, Tim Andres, Ye, Wei, Sommers, Cynthia D., Rodriguez, Jason D., Keire, David A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Rapid Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7329790/
https://www.ncbi.nlm.nih.gov/pubmed/32613429
http://dx.doi.org/10.1208/s12248-020-00473-w

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