Comprehensive Analytical Data Record for Stability Studies of Chiral Drugs
This template is used to capture stability data for chiral drugs, focusing on enantiomeric purity, degradation, and stability across different storage conditions.
| Parameter | Details |
|---|---|
| Product Name | [Chiral Drug Name] |
| Batch Number | [Batch Number] |
| Test Parameters |
– Enantiomeric Purity – Assay  – Optical Rotation |
| Storage Conditions | [e.g., 25°C, 60% RH] |
| Test Intervals | [Specify testing intervals] |
| Results Summary | [Summarize findings at each interval] |
| Signatures | QA, QC, Regulatory Affairs |