T/SHDSGY 186-2022 Active Group standards

T/SHDSGY 186-2022 Phosphormycin Amylenglycol Genotoxicity Impurity Analysis Technical Specification

Publish Date: 2022-12-27 Implement Date: 2022-12-27 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/SHDSGY 186-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2022-12-27

Implement Date: 2022-12-27

Scope

Main technical content: This document specifies the terms and definitions of the analysis technology specification for genotoxic impurities in fosfomycin tromethamine, instruments and test drugs, experimental methods, and provides the results of method validation. This document is applicable to the entire process of genotoxic impurity analysis for fosfomycin series products (fosfomycin tromethamine, fosfomycin sodium, and fosfomycin calcium).