GB/T 26367-2020 in English

Core changes in the standard and technical upgrades

Analysis of key indicators

1. Active ingredient limit requirements

Set strict concentration limits based on application scenarios:

• Skin disinfection: Chlorhexidine≤45g/L
• Mucous membrane disinfection: Polyhexamethyleneguanidine≤3g/L
• Heavy metal limits: Lead ≤10mg/kg, Mercury ≤1mg/kg

2. Microbial killing efficacy

The standard requires that for common pathogens:

• Suspension method: Escherichia coli killing logarithm ≥ 5.00
• Carrier method: Candida albicans killing logarithm ≥ 3.00
• Field test: natural bacteria killing logarithm ≥ 1.00

Implementation and application suggestions

1. Production quality control

Raw material purity requirements:

• Chlorhexidine acetate≥97.5% (dry product)
• EthanolConforms to the standards of the Chinese Pharmacopoeia
• Production water must comply with the first-level standard of GB/T6682

2. Stability management

Validity period verification standard:

• 12-month product: active ingredient decline rate ≤10%
• 24-month products: must pass accelerated aging test

3. Precautions for use

Specify prohibited situations:

• Not suitable for disinfection of mycobacteria and bacterial spores
• Single-ingredient preparations cannot inactivate non-enveloped viruses
• Mucous membrane disinfection requires strict concentration control

Innovation in detection technology

Introduction of new standards:

1. High performance liquid chromatography: can simultaneously detect the three forms of chlorhexidine
2. Capillary electrophoresis: achieve accurate identification of PHMG/PHMB
3. Eosin Y colorimetric method: dedicated to rapid detection of polyhexamethylene guanidine