Identification and genotoxicity evaluation of potential impurities in rabeprazole sodium using in silico and in vitro analyses-Reference-Cited by-同舟云学术

Identification and genotoxicity evaluation of potential impurities in rabeprazole sodium using in silico and in vitro analyses

Published:2021-04-08 Issue: Volume: Page:1-7
ISSN:0148-0545
Container-title:Drug and Chemical Toxicology
language:en
Short-container-title:Drug and Chemical Toxicology

Author:

Du Yi¹,Wu Yinnan²³,Liu Yang³,Meng Changhong³,Tan Li³,Cai Tiantian¹,Wang Yuxin³,Lu Yihong²³

Affiliation:

1. The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, China

2. Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University, Xuzhou, China

3. Key Laboratory for Impurity Profile of Chemical Drugs, National Medical Products Administration, Jiangsu Institute for Food and Drug Control, Nanjing, China

Funder

Chinese Pharmacopoeia Commission

Publisher

Informa UK Limited

Subject

Chemical Health and Safety,Health, Toxicology and Mutagenesis,Public Health, Environmental and Occupational Health,Pharmacology,Toxicology,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/01480545.2021.1908712

Reference17 articles.

1. Methods for detecting carcinogens and mutagens with the salmonella/mammalian-microsome mutagenicity test

2. Genotoxicity and carcinogenicity testing of pharmaceuticals: Correlations between induction of DNA lesions and carcinogenic activity

3. Genotoxic and carcinogenic effects of gastrointestinal drugs

4. ICH M7(R1), 2016. Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk [online]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_R1_Addendum_Step_4_2017_0031.pdf [Accessed 10 November 2016].

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