T/CAS 601-2022 Active Group standards

T/CAS 601-2022 Research technical specifications for quality and safety testing indicators of traditional Chinese medicine injections

Publish Date: 2022-05-27 Implement Date: 2022-05-27 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/CAS 601-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Integrated services in the fields of medicine, health, and labor protection

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2022-05-27

Implement Date: 2022-05-27

Scope

Scope: This document specifies the technical guidelines, indicator detection methods, pre-limit setting research, and limit setting for the quality and safety assessment of traditional Chinese medicine injections (for intravenous use). The indicators include: protein, tannins, resins, oxalates, potassium ions, bacterial endotoxins (or pyrogens), hemolysis and coagulation, abnormal toxicity, allergic reactions, hypotensive substances, pyrolysis residues, visible foreign matter, insoluble particles, sterility, residual solvents, elemental impurities, high-molecular-weight substances, 5-hydroxymethylfurfural, allergic-like reactions, genetic toxicity impurities, and other toxic components. This document is applicable to the research on quality and safety assessment indicators of traditional Chinese medicine injections (for intravenous use). Main technical content: 1. Scope: This document specifies the technical guidelines, indicator detection methods, pre-limit setting research, and limit setting for the quality and safety assessment of traditional Chinese medicine injections (for intravenous use). The indicators include: protein, tannins, resins, oxalates, potassium ions, bacterial endotoxins (or pyrogens), hemolysis and coagulation, abnormal toxicity, allergic reactions, hypotensive substances, pyrolysis residues, visible foreign matter, insoluble particles, sterility, residual solvents, elemental impurities, high-molecular-weight substances, 5-hydroxymethylfurfural, allergic-like reactions, genetic toxicity impurities, and other toxic components. This document is applicable to the research on quality and safety assessment indicators of traditional Chinese medicine injections (for intravenous use). 2. Normative references: The following documents are essential for the application of this document. For dated reference documents, only the version dated on that date is applicable to this document. For undated reference documents, the latest version (including all amen