Table 5 Typical Q6A parameters to Evaluate for a Drug-Based Stability Program
From: Stability considerations for drug-device combination products-21 CFR part 4 update
Testing Category | Tests to be Considered |
|---|---|
Chemical testing | - Assay for Active Pharmaceutical Ingredient (API)- Impurity/Degradation Products- Photostability (if applicable) |
Physical testing | - Appearance - Dissolution/Rate of release - Molecular Weight and Polydispersity of polymeric components in device and coating -Tensile strength of bonded device components |
Microbiological testing | - Sterility - Particulate matter - Bacterial Endotoxin - Antimicrobial Effectiveness |