Comprehensive Stability Study Protocol for Nasal Gel Products
This protocol outlines the procedures for conducting stability studies on nasal gel products, focusing on viscosity, microbial stability, and drug release profiles under varying storage conditions.
| Parameter | Details |
|---|---|
| Product Name | [Nasal Gel Product Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the stability of nasal gels under specified storage conditions. |
| Test Parameters |
– Viscosity – Microbial Stability  – Appearance |
| Storage Conditions | [e.g., 25°C/60% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant changes in viscosity, microbial stability, or drug release profile. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |