T/ZYNY 001-2025 Active Group standards

T/ZYNY 001-2025 Antibacterial Liquid for Tongbi Shuimei

Publish Date: 2025-02-10 Implement Date: 2025-02-20 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/ZYNY 001-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2025-02-10

Implement Date: 2025-02-20

Scope

Scope: This document specifies the technical requirements, test methods, inspection rules, marking, labeling, packaging, transportation, and storage of Tongbi Shubai Liquid. This standard applies to Tongbi Shubai Liquid products made from raw materials such as dry ginger, Asarum, Schisandra, raw licorice, ephedra, aconite, semen nigri, rhubarb, frankincense, myrrh, coptis chinensis, coptis japonica, lei gong teng, chicken blood vine, angelica, rhizoma coptidis, cinnamon twig, cassia twig, Achyranthes aspera, and others. These products must meet the requirements of the "WS 628-2018 Technical Guidelines for the Hygienic and Safety Evaluation of Disinfection Products". Main technical content: 3.1 Raw materials: All raw materials must comply with the requirements of the "WS 628-2018 Technical Guidelines for the Hygienic and Safety Evaluation of Disinfection Products". 3.2 Sensory characteristics: - Form: Liquid - Color: Yellow - Odor: Slightly acidic, with no obvious foreign odors. A small amount of sediment is allowed after long-term storage. 3.3 Physicochemical indicators: - pH value (25°C): 0.2±0.02%, ranging from 2.0 to 9.0 - Limit values for heavy metals: Mercury ≤ 1mg/kg, lead ≤ 10mg/kg, arsenic ≤ 2mg/kg 3.4 Microbiological indicators: - Total bacterial count (CFU/mL): <200 - Escherichia coli/mL: Not detected - Pseudomonas aeruginosa/mL: Not detected - Hemolytic streptococcus/mL: Not detected - Staphylococcus aureus/mL: Not detected - Total fungal count (CFU/mL): <100 3.5 Antibacterial indicators: - Escherichia coli: Effective solution, 2 minutes, inhibition rate ≥ 30% - Staphylococcus aureus: Effective solution, 2 minutes, inhibition rate ≥ 30% - Candida albicans: Effective solution, 2 minutes, inhibition rate ≥ 30%