Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products-Reference-Cited by-同舟云学术

Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

Published:2019-04 Issue: Volume:103 Page:325-329
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Snodin David J.,Elder David P.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference44 articles.

1. Carry Over of Impurities: A Detailed Exemplification for Glycopyrrolate (NVA237)

2. Benzene as a Contaminant. Anderson's Process Solutions;Anderson,2016

3. Determination of NDMA in Valsartan Active Substances and Finished Products by HPLC/UV Method Reference : 18A0399-02. 21 September 2018;ANSM (French National Agency for Medicines and Health Products Safety),2018

4. Origin of the TTC values for compounds that are genotoxic and/or carcinogenic and an approach for their re-evaluation

5. A tiered approach to threshold of regulation

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