Ranitidine—Investigations into the Root Cause for the Presence of N-Nitroso-N,N-dimethylamine in Ranitidine Hydrochloride Drug Substances and Associated Drug Products-Reference-Cited by-同舟云学术

Ranitidine—Investigations into the Root Cause for the Presence of N-Nitroso-N,N-dimethylamine in Ranitidine Hydrochloride Drug Substances and Associated Drug Products

Published:2020-12-01 Issue:12 Volume:24 Page:2915-2926
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

King Fiona J.¹,Searle Andrew D.¹^ORCID,Urquhart Michael W.¹^ORCID

Affiliation:

1. Medicines Research Centre, GlaxoSmithKline, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.0c00462

Reference23 articles.

1. https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity-some (accessed May 2018).

2. https://www.ema.europa.eu/en/medicines/human/referrals/angiotensin-ii-receptor-antagonists-sartans-containing-tetrazole-group (accessed September 2018).

3. https://www.ema.europa.eu/en/documents/press-release/ema-review-ranitidine-medicines-following-detection-ndma_en.pdf (accessed September 2019).

4. Allen & Hanbury’s Ltd.; Price, B. J.; Clitherow, J. W.; Bradshaw, J. Aminoalkyl furan derivatives. GB 1565966 A, 1977, which claims priority to applications filed in 1976.

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