Determination of epoxide impurity in sarpogrelate hydrochloride intermediate by UHPLC and column-switching liquid chromatography-Reference-Cited by-同舟云学术

Determination of epoxide impurity in sarpogrelate hydrochloride intermediate by UHPLC and column-switching liquid chromatography

Published:2019-09 Issue: Volume:174 Page:57-62
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Wang Ran,Zhu Zhiling,Qiu Xiaodan,Bai Liping,Guo Weiwei,Zuo Limin,Zhao Ting,Shan Guangzhi

Funder

CAMS Initiative for Innovative Medicine

National Major Scientific and Technological Special Project for “Significant New Drugs Development

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference29 articles.

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3. EMEA, Committee for Medicinal Products (CHMP). Guideline on the Limits of Genotoxic Impurities, EMEA, London, 2006, CPMP/SWP/5199/02, June 28 2006.

4. USFDA, Guidelines for industry; Genotoxic and carcinogenic impurities in drug substances and products: recommended approaches (draft), December 2008.

5. ICH M7. Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, June 2014.

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