Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets

Autor: Shakleya, Diaa, Alayoubi, Alaadin, Brown, Dustin, Mokbel, Alaa, Abrigo, Nicolas, Mohammad, Adil, Wang, Jiang, Li, David, Shaklah, Maha, Alsharif, Fahd M., Desai, Saaniya, Essandoh, Martha, Faustino, Patrick J., Ashraf, Muhammad, O’ Connor, Thomas, Vera, Matthew, Raw, Andre, Sayeed, Vilayat A., Keire, David

Publikováno v: In International Journal of Pharmaceutics 5 December 2024 666

A headspace GC-MS method to quantify nitrosamine impurities and precursors in drug products: Method validation and product testing.

Autor: Selaya SD; Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA.; Office of Product Quality Assessment, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA., Abrigo N; Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA.; Office of Product Quality Assessment, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA., Brown DG; Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA., Desai S; Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA., Beekman C; Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA.; Office of Regulatory Science, Center for Food Safety and Applied Nutrition, College Park, Maryland, USA., Faustino P; Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA., Shakleya D; Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Biomedical chromatography : BMC [Biomed Chromatogr] 2024 Nov 07, pp. e6040. Date of Electronic Publication: 2024 Nov 07.