Comprehensive Stability Study Protocol for Drug-Eluting Stents
This protocol outlines the procedures for conducting stability studies on drug-eluting stents, evaluating their drug release profile, coating integrity, and sterility over time under various storage conditions.
| Parameter | Details |
|---|---|
| Product Name | [Drug-Eluting Stent Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of the drug-eluting stent under specified environmental conditions. |
| Test Parameters |
– Drug Release Profile – Coating Integrity  |
| Storage Conditions | [e.g., 25°C/60% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6, 12 months, etc.] |
| Acceptance Criteria | No significant change in drug release profile, coating integrity, or sterility. |
| Regulatory Guidelines | ICH Q1A(R2), FDA |
| Signatories | QA, QC, Regulatory Affairs |