Synthesis and mutagenic risk of avanafil's potential genotoxic impurities-Reference-Cited by-同舟云学术

Synthesis and mutagenic risk of avanafil's potential genotoxic impurities

Published:2024 Issue:30 Volume:14 Page:21432-21438
ISSN:2046-2069
Container-title:RSC Advances
language:en
Short-container-title:RSC Adv.

Author:

Sun Yunkai¹²^ORCID,Wu Xiaoxia²³,Zuo Pei³,Liu Zhao³,Miao Xuepei¹,Liu Jian¹,Wen Hairuo⁴

Affiliation:

1. School of Chemical Engineering and Materials, Changzhou Institute of Technology, Changzhou 213022, China

2. School of Chemistry and Chemical Engineering, University of South China, Hengyang 421001, China

3. Harvest Pharmaceutical Co., Ltd, Changsha 410000, China

4. National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs, Beijing, 100176, P. R. China

Abstract

Imp-E and Imp-F with altering hydrazide-structure were synthesized, which were determined to be negative for genotoxicity and could be controlled as class 5 in ICH M7.

Funder

Natural Science Foundation of Hunan Province

Natural Science Research of Jiangsu Higher Education Institutions of China

Changzhou Institute of Technology

Publisher

Royal Society of Chemistry (RSC)

Link

http://pubs.rsc.org/en/content/articlepdf/2024/RA/D4RA02345E

Reference31 articles.

1. Efficacy and safety of avanafil as compared with sildenafil in the treatment of erectile dysfunction: A randomized, double blind, multicenter clinical trial

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3. Industrial approaches and consideration of clinical relevance in setting impurity level specification for drug substances and drug products

4. Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends