T/ZSHG 024-2023 Composite Lysing Enzyme Children's Oral Antimicrobial Cleaning and Care Solution

Scope

Scope: This document applies to compound lysozyme oral antibacterial/antiseptic cleaning solution for children, with common products including children's compound lysozyme oral antibacterial/antiseptic rinse and children's compound lysozyme oral spray. This document does not apply to medical oral rinse solutions and foaming toothpaste. Main technical contents: pH (25℃, 1% aqueous solution): 3.0~10.5 Main active ingredients and their content: Lysozyme enzymatic activity (U/mL) ≥ 36,000; Staphylococcus lysozyme enzymatic activity (U/mL) ≥ 0.85 Free fluoride or soluble fluoride content (%): 0.02~0.11 Fluoride ion content (mg/bottle) (%): ≤ 125 Microbial killing indicators: Antibacterial: Escherichia coli, Staphylococcus aureus, and Candida albicans with a killing rate ≥ 90% Antiseptic: Escherichia coli, Staphylococcus aureus, and Candida albicans with an inhibitory rate ≥ 50% Harmful substance limits: Lead (Pb) ≤ 10mg/kg Arsenic (As) ≤ 2mg/kg Mercury (Hg) ≤ 1mg/kg Cadmium (Cd) ≤ 5mg/kg Methanol [when ethanol or isopropanol is added to the formula, this indicator should be tested] ≤ 150mg/kg

Development Information

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