Investigating the root cause of N-nitrosodimethylamine formation in metformin pharmaceutical products-Reference-Cited by-同舟云学术

Investigating the root cause of N-nitrosodimethylamine formation in metformin pharmaceutical products

Published:2021-04-22 Issue:7 Volume:20 Page:855-862
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Nasr Nasr Eldin Hussein¹,Metwaly Metwaly Gamel¹,Ahmed Eman Osama¹,Fares Ahmed Roshdy²,ElMeshad Aliaa Nabil²³

Affiliation:

1. Research and Development Department, Al Esraa Pharmaceutical Optima, Badr City, Cairo, Egypt

2. Pharmaceutics and Industrial Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt

3. Faculty of Nanotechnology for Postgraduate Studies, Cairo University, El-Sheikh Zayed, Giza, Egypt

Funder

Al Esraa Pharmaceutical Optima

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2021.1917547

Reference33 articles.

1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Pharmaceutical Quality/Manufacturing Standards/Current Good Manufacturing Practice (CGMP). Revision 1, control of nitrosamine impurities in human drugs, guidance for industry. 2021. New Hampshire Ave. [cited 2021 Apr 8]. Available from: https://www.fda.gov/media/141720/download.

2. World Health Organization. Essential medicines and health products, information note nitrosamine impurities, update on nitrosamine impurities. [cited 2019 Nov 20]. Available from: https://www.who.int/medicines/publications/drugalerts/InformationNote_Nitrosamine-impurities/en/.

3. US Environmental Protection Agency (EPA). Technical fact sheet – NDMA. Washington, DC: US Environmental Protection Agency. [cited 2021 Apr 8]. Available from: https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf

4. N-Nitrosodimethylamine-Mediated Formation of Oxidized and Methylated DNA Bases in a Cytochrome P450 2E1 Expressing Cell Line

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