StabilityStudies.in
Comprehensive Stability Study Protocol for Drugs in Novel Packaging
This protocol outlines the procedures for conducting stability studies on drug products in novel packaging systems. The study evaluates how innovative packaging protects drug products from environmental factors, including light, moisture, and oxygen.
| Parameter | Details |
|---|---|
| Product Name | [Product Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of drugs in novel packaging systems under specified conditions. |
| Test Parameters |
– Assay  – Degradation Products – Physical Integrity |
| Storage Conditions | [e.g., 25°C/60% RH, 40°C/75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6, 12 months, etc.] |
| Acceptance Criteria | No significant changes in assay, barrier properties, or physical integrity. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |
StabilityStudies.in