Stability Study Protocol for Drug-Eluting Stent

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Stability Study Protocol for Drug-Eluting Stent

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 “Future of Drug Stability: How Pharmaceutical Stress Testing Safeguards Against Degradation and Ensures Medication Efficacy” /> – Sterility
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

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