T/ZZB 2564-2021 Active Group standards

T/ZZB 2564-2021 Atorvastatin Calcium

Publish Date: 2021-09-15 Implement Date: 2021-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/ZZB 2564-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Drugs for the cardiovascular, respiratory, and blood systems

ICS Name: Medical materials

Publish Date: 2021-09-15

Implement Date: 2021-10-15

Scope

Main technical content: This document specifies the basic requirements, technical requirements, test methods, inspection rules, labeling, packaging, transportation and storage, quality commitments, etc. of Atorvastatin Calcium. This document is applicable to Atorvastatin Calcium (the chemical name, structure, molecular formula, etc. of which are shown in Appendix A) prepared from 2-[4R,6R)-6-[2-[2- (4-fluorophenyl)-3-phenyl-4-phenylcarbamoyl]-5-isopropylpyrrole-1-yl]ethyl]-2,2-dimethyl-1,3-dioxolane-4-yl acetate tert-butyl ester (referred to as L1) as the starting material, through acid hydrolysis, alkali hydrolysis, and salt formation processes.