Quantitative <sup>31</sup>P-NMR for the Purity Determination of the Organophosphorus Compound Brigatinib and Its Method Validation

Author:

Uchiyama Nahoko1,Hosoe Junko1,Komatsu Takanori2,Sugimoto Naoki1,Ishizuki Kyoko1,Koide Tatsuo1,Murabayashi Mika3,Shinozaki Taeko4,Kobayashi Kengo4,Fujimine Yoshinori5,Ofuji Katsuya6,Shimizu Hitoshi6,Hasebe Takashi7,Asai Yumi7,Ena Eri7,Kiyota Kohei8,Fujita Kazuhiro8,Makino Yoshinobu9,Miura Toru10,Muto Yasuhiro10,Asakura Katsuo2,Suematsu Takako2,Muto Hitomi2,Kohama Ai11,Goto Takashi12,Yasuda Masu12,Ueda Tomohiko13,Goda Yukihiro1

Affiliation:

1. National Institute of Health Sciences (NIHS)

2. JEOL Ltd.

3. Takeda Pharmaceutical Co., Ltd.

4. Daiichi Sankyo Co., Ltd.

5. Otsuka Pharmaceutical Co., Ltd.

6. Chugai Pharmaceutical Co., Ltd.

7. Eisai Co., Ltd.

8. Shionogi & Co., Ltd.

9. Juzen Chemical Corp.

10. FUJIFILM Wako Pure Chemical Corporation

11. Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)

12. Nippon Shinyaku Co., Ltd.

13. Sumitomo Pharma Co., Ltd.

Publisher

Pharmaceutical Society of Japan

Subject

Drug Discovery,General Chemistry,General Medicine

Reference13 articles.

1. 1) The Ministry of Health, Labour and Welfare, Japan. “The Japanese Pharmacopoeia Eighteen Edition (2021).”: ‹https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000066597.html›, cited 2 September, 2023.

2. 2) Hosoe J., Sugimoto N., Goda Y., Pharmaceutical and Medical Device Regulatory Science, 41, 960–970 (2010).

3. 3) Hosoe J., Sugimoto N., Suematsu T., Yamada Y., Hayakawa M., Katsuhara T., Nishimura H., Goda Y., Pharmaceutical and Medical Device Regulatory Science, 43, 182–193 (2012).

4. 4) Hosoe J., Sugimoto N., Suematsu T., Yamada Y., Miura T., Hayakawa M., Suzuki H., Katsuhara T., Nishimura H., Kikuchi Y., Yamashita T., Goda Y., Pharmaceutical and Medical Device Regulatory Science, 45, 243–250 (2014).

5. 5) Goda Y., Pharmaceutical and Medical Device Regulatory Science, 48, 615–619 (2017).

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