Analysis of an Impurity, <i>N</i>-Nitrosodimethylamine, in Valsartan Drug Substances and Associated Products Using GC-MS-Reference-Cited by-同舟云学术

Analysis of an Impurity, N-Nitrosodimethylamine, in Valsartan Drug Substances and Associated Products Using GC-MS

Published:2019-04-01 Issue:4 Volume:42 Page:547-551
ISSN:0918-6158
Container-title:Biological and Pharmaceutical Bulletin
language:en
Short-container-title:Biol. Pharm. Bull.

Author:

Tsutsumi Tomoaki¹,Akiyama Hiroshi¹,Demizu Yosuke¹,Uchiyama Nahoko¹,Masada Sayaka¹,Tsuji Genichiro¹,Arai Ryoko¹,Abe Yasuhiro¹,Hakamatsuka Takashi¹,Izutsu Ken-ichi¹,Goda Yukihiro¹,Okuda Haruhiro¹

Affiliation:

1. National Institute of Health Sciences

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology,General Medicine

Link

https://www.jstage.jst.go.jp/article/bpb/42/4/42_b19-00006/_pdf

Reference16 articles.

1. 1) Ministry of Health, Labour and Welfare, Japan. Press release “Iyakuhin jishu kaishū no oshirase (class 1).”, 6 July, 2018: ‹https://www.mhlw.go.jp/stf/newpage_00086.html›, cited 11 December, 2018.

2. 2) IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. IARC Monographs on the evaluation of the carcinogenic risk of chemicals to humans. Some N-Nitroso Compounds, 17, 125–175 (1978).

3. 3) Ministry of Health, Labour and Welfare, Japan. Notification “Barusarutan seizai ni okeru hatsugan busshitsu no kenshutsu ni taisuru taiō ni tsuite.” 7 September, 2018: ‹https://www.mhlw.go.jp/content/11121000/000360273.pdf›, cited 11 December, 2018.

4. 4) ASKA Pharmaceutical Co., Ltd. “Barusarutan jō ‘AA’ ni kakaru seihin kaishū oyobi sesshu ni tomonau risuku hyōka ni kansuru hōkoku-sho.” 25 August 2018: ‹https://www.mhlw.go.jp/content/11121000/000360269.pdf›, cited 11 December, 2018.

5. 5) European Medicines Agency. “Update on review of valsartan medicines due to detection of NDMA: EMA reviewing valsartan produced by another company Zhejiang Tianyu.” 10 August, 2018: ‹ https://www.ema.europa.eu/en/news/update-review-valsartan-medicines-due-detection-ndma-ema-reviewing-valsartan-produced-another›, cited 11 December, 2018.

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