Antibiotic potency testing is governed by several major pharmacopeias, each with specific requirements and methodologies.
USP Requirements
General Chapter <81>
The United States Pharmacopeia provides comprehensive guidance for microbial assays of antibiotics including:
- Test organism specifications
- Medium preparation requirements
- Zone measurement procedures
- Potency calculation methods
BP Requirements
Appendix XIV
The British Pharmacopeia specifies:
- Biological assay procedures
- Reference standard requirements
- Statistical analysis methods
- Acceptance criteria
EP Requirements
Section 2.7.2
The European Pharmacopeia details:
- Microbiological assay of antibiotics
- Agar diffusion methods
- Turbidimetric procedures
- Validation requirements
JP Requirements
The Japanese Pharmacopeia provides:
- Country-specific test organisms
- Medium compositions
- Calculation methods
- Quality specifications
Common Elements
Zone Measurement
All pharmacopeias require accurate zone diameter measurement. The Antibiotic Zone Reader ensures compliance with:
- High precision (0.01 mm resolution)
- Consistent measurement technique
- Documented results
Statistical Analysis
Parallel line or slope ratio calculations are used to determine potency relative to reference standards.
Documentation
All methods require complete records of:
- Standard and sample preparations
- Zone measurements
- Calculations and results
- Analyst identification
Choosing the Right Method
Selection depends on:
- Market requirements
- Regulatory submissions
- Available reference standards
- Laboratory capabilities