Comprehensive Stability Study Protocol for Chiral Drugs
This protocol outlines the procedures for conducting stability studies on chiral drugs, assessing the enantiomeric purity, degradation, and potential changes in stereochemistry over time.
| Parameter | Details |
|---|---|
| Product Name | [Chiral Drug Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of chiral drugs under various environmental conditions. |
| Test Parameters |
– Enantiomeric Purity – Assay –  – Optical Rotation |
| 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 changes in enantiomeric purity or stereochemistry. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |