Nitrosamine Impurities in Pharmaceuticals: An Empirical Review of their Detection, Mechanisms, and Regulatory Approaches.

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第一作者： Darshan,Bhirud

第一单位： School of Pharmacy & Technology Management, SVKM'S NMIMS Deemed-to-be University, Shirpur, Maharashtra, 425405, India.

作者： Darshan,Bhirud ^[1] ; Gyan,Agrawal ^[1] ; Harshil,Shah ^[2] ; Artiben,Patel ^[3] ; Mahesh B,Palkar ^[1] ; Sankha,Bhattacharya ^[1] ; Bhupendra G,Prajapati ^[4]

作者单位： School of Pharmacy & Technology Management, SVKM'S NMIMS Deemed-to-be University, Shirpur, Maharashtra, 425405, India. ^[1] Department of Bioequivalence, Cosette Pharmaceuticals INC, 200 Crossing Blvd Fl 4, Bridgewater, New Jersey, 08807, United States. ^[2] Department of Regulatory Affairs, Cosette Pharmaceuticals Inc., 200 Crossing Blvd Fl 4, Bridgewater, New Jersey, 08807, United States. ^[3] Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, 384012, India. ^[4]

关键词 Drug substance life cycle FDA.Global Substance Registration System (GSRS)ICH Q3A-Q3E N-nitroso dimethyl amine (NDMA)Nitrosamines

主题词亚硝胺类(Nitrosamines);药物污染(Drug Contamination);人类(Humans);药用制剂(Pharmaceutical Preparations)

DOI 10.2174/0115680266278636240125113509

PMID 38321910

发布时间 2024-05-31

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