Comprehensive Stability Study Protocol for Polymorphic Drugs
This protocol outlines the procedures for conducting stability studies on polymorphic drugs, focusing on polymorph stability, dissolution, and potential transformation under different conditions.
| Parameter | Details |
|---|---|
| Product Name | [Polymorphic Drug Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the stability of polymorphic drugs under specified environmental conditions. |
| Test Parameters |
– Polymorph Stability – Dissolution  |
| Storage Conditions | [e.g., 25°C/60% RH, 40°C/75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant change in polymorph stability or dissolution rate. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |