Simple and Practical Method for the Quantitative High-Sensitivity Analysis of <i>N</i>-Nitroso Duloxetine in Duloxetine Drug Products Utilizing LC-MS/MS-Reference-Cited by-同舟云学术

Simple and Practical Method for the Quantitative High-Sensitivity Analysis of N-Nitroso Duloxetine in Duloxetine Drug Products Utilizing LC-MS/MS

Published:2024-03-08 Issue: Volume: Page:
ISSN:2470-1343
Container-title:ACS Omega
language:en
Short-container-title:ACS Omega

Author:

Fukuda Shohei¹^ORCID,Nakase Yumiko²,Imagaki Kazuhide²,Kondo Kanako³,Taniguchi Takahiko⁴,Uchikawa Osamu⁴

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., 32-8 Kuwazaishinmachi, Kadoma, Osaka 571-0043, Japan

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

4. Towa Pharmaceutical Co., Ltd., 2-11 Shinbashi-cho, Kadoma, Osaka 571-8580, Japan

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acsomega.4c00136

Reference16 articles.

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3. FDA Release. Guidance for Industry. Control of Nitrosamine Impurities in Human Drugs 2021 https://www.fda.gov/media/141720/download (accessed January 30, 2024).

4. PMDA Release. Self-Inspection on Risks of Contamination with Nitrosamines in Drugs 2021 https://www.pmda.go.jp/files/000243438.pdf (accessed January 30, 2024).

5. A genome-wide portrait of pervasive drug contaminants