An automated carcinogenic potency categorization approach for nitrosamine drug substance-related impurities-Reference-Cited by-同舟云学术

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An automated carcinogenic potency categorization approach for nitrosamine drug substance-related impurities

Published:2024 Issue: Volume: Page:
ISSN:1463-9262
Container-title:Green Chemistry
language:en
Short-container-title:Green Chem.

Author:

Zhu Jiazhou¹^ORCID,Qu Yang¹,Ye Ning¹^ORCID

Affiliation:

1. Suzhou Novartis Technical Development Co., Ltd, Changshu, Jiangsu 215537, China

Abstract

A web-based application that can autonomously analyze the risk category of N-nitrosamine compounds from their SMILES notation, providing instant screening to identify high-risk formations of N-nitrosamines.

Publisher

Royal Society of Chemistry (RSC)

Subject

Pollution,Environmental Chemistry

Link

http://pubs.rsc.org/en/content/articlepdf/2024/GC/D3GC03478J

Reference13 articles.

1. FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity, https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containing-valsartan-following-detection-impurity

2. Information on Nitrosamines for Marketing Authorisation Holders; EMA/189634/2019 . European Medicines Agency , 2019

3. The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny

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

5. Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond

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