✅ Quality Control Standards

🧪 Testing Requirements

Chemical Analysis

• Purity Testing: Chemical composition verification
• Structure Verification: Spectroscopic methods
• Functional Activity: Binding capacity assays
• Stability Assessment: Long-term storage studies

Physical Testing

• Particle Size: 20-50nm distribution
• Surface Properties: Charge and morphology
• Batch Uniformity: Consistency validation
• Stability Parameters: Temperature/pH range

📋 Quality Standards

Specifications

• Purity: ≥99.5% active compound
• Binding Activity: Kd ≤ 0.3 nM
• BBB Transit: ≥95% efficiency
• Stability: 24+ months shelf life

Release Criteria

• Chemical Compliance: All specs met
• Biological Activity: Functional verification
• Safety Parameters: Toxicity cleared
• Documentation: Complete records

📊 Documentation Systems

• Test Records: Complete analytical data
• SOPs: Standardized procedures
• Training Records: Personnel qualification
• Compliance: Regulatory requirements