Comprehensive Stability Study Protocol for Evaluating the Impact of Humidity on Drug Products
This protocol outlines the procedures for conducting stability studies on drug products to assess the impact of different humidity conditions on physical and chemical properties.
| Parameter | Details |
|---|---|
| Product Name | [Product Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the impact of humidity on drug stability. |
| Test Parameters |
– Moisture Content – Degradation Products  – Physical Appearance |
| Humidity Conditions | [e.g., 40%, 60%, 75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant changes in moisture content, degradation, or dissolution profile. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |