<i>N</i>-Nitrosodimethylamine Formation in Metformin Drug Products by the Reaction of Dimethylamine and Atmospheric NO<sub>2</sub>-Reference-Cited by-同舟云学术

N-Nitrosodimethylamine Formation in Metformin Drug Products by the Reaction of Dimethylamine and Atmospheric NO₂

Published:2023-11-02 Issue:11 Volume:27 Page:2123-2133
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Fukuda Shohei¹,Kondo Kanako²,Fukumoto Shoji³^ORCID,Takenaka Norimichi⁴,Uchikawa Osamu⁵,Yoshida Itsuro⁵

Affiliation:

1. R&D Division, Analytical Technology Unit, API Analytical Development Department, Towa Pharmaceutical Co., LTD., 7-1-3 Doi-cho, Amagasaki, Hyogo 660-0083, Japan

2. R&D Division, Analytical Technology Unit, API Analytical Development Department, Towa Pharmaceutical Co., LTD., 26-7 Ichiban-cho, Kadoma, Osaka 571-0033, Japan

3. R&D Division, API Business Unit, Towa Pharmaceutical Co., LTD., 2-5-15 Hiyoshi-cho, Moriguchi , Osaka 570-0081, Japan

4. Division of Sustainable System Sciences, Graduate School of Sustainable System Sciences, Osaka Metropolitan University, 1-1 Gakuen-cho, Nakaku, Sakai, Osaka 599-8531, Japan

5. Towa Pharmaceutical Co., LTD., 2-11 Shinbashi-cho, Kadoma, Osaka 571-8580, Japan

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.3c00274

Reference48 articles.

1. Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

2. Heads of Medicines Agency. Lessons learnt from presence of N-nitrosamine impurities in sartan medicines; 2020. https://www.ema.europa.eu/en/documents/report/lessons-learnt-presence-n-nitrosamine-impurities-sartan-medicines_en.pdf (accessed September 2023).

3. Suspension of ranitidine medicines in the EU. EMA/231394/2020. European Medicines Agency, April 30, 2020. https://www.ema.europa.eu/en/news/suspension-ranitidine-medicines-eu (accessed September 2023).

4. FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine, September 13, 2019. https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine (accessed September 2023).

5. Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-nizatidine-oral-solution-15-mgml-due (accessed September 2023).

Cited by 6 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Nitrosamine contamination of pharmaceuticals: Cases in Japan, formation mechanisms, detection methods, regulatory perspectives, and insights;Journal of Pharmaceutical and Biomedical Analysis Open;2024-12

2. On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes;Current Opinion in Chemical Engineering;2024-09

3. Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study;Organic Process Research & Development;2024-08-06

4. Simple and Practical Method for the Quantitative High-Sensitivity Analysis of N-Nitroso Duloxetine in Duloxetine Drug Products Utilizing LC-MS/MS;ACS Omega;2024-03-08

5. Risk Assessment Study of Nitrosamines for the API Temozolomide Industrial Process;Organic Process Research & Development;2024-01-24