StabilityStudies.in
Comprehensive Stability Study Protocol for Hormone Replacement Therapies (HRT)
This protocol outlines the procedures for conducting stability studies on hormone replacement therapies, assessing hormone potency, degradation products, and microbial stability under varying conditions.
| Parameter | Details |
|---|---|
| Product Name | [Hormone Replacement Therapy Product Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the stability of hormone replacement therapies under specified conditions. |
| Test Parameters |
– Hormone Potency – Degradation Products  – Appearance |
| Storage Conditions | [e.g., 25°C/60% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant changes in potency, degradation products, or microbial stability. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |
StabilityStudies.in