Formation of <i>N</i>-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies-Reference-Cited by-同舟云学术

Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Published:2023-07-21 Issue: Volume: Page:
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Cioc Răzvan C.¹²,Joyce Ciarán¹,Mayr Monika¹,Bream Robert N.¹^ORCID

Affiliation:

1. European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands

2. Leiden University Medical Centre (LUMC), Klinische Farmacie en Toxicologie Afdeling, Albinusdreef 2, 2333 ZA Leiden, The Netherlands

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.3c00153

Reference93 articles.

1. European Medicines Agency (EMA). Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group. 2021. https://www.ema.europa.eu/en/medicines/human/referrals/angiotensin-ii-receptor-antagonists-sartans-containing-tetrazole-group.

2. European Medicines Agency (EMA). Ranitidine-containing medicinal products. 2020. https://www.ema.europa.eu/en/medicines/human/referrals/ranitidine-containing-medicinal-products.

3. Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA)

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