Comprehensive Analytical Data Record for Ophthalmic Ointment Stability Studies
This document records stability data for ophthalmic ointments, assessing the stability of the active ingredients and physical characteristics under various storage conditions.
| Parameter | Details |
|---|---|
| Product Name | [Ophthalmic Ointment Name] |
| Batch Number | [Batch Number] |
| Test Parameters |
– Appearance – Assay – Viscosity  – pH – Microbial Limits |
| Storage Conditions | [e.g., 25°C, 60% RH] |
| Test Intervals | [0, 3, 6 months, etc.] |
| Results Summary | [Key findings from each interval] |
| Signatories | QA, QC, Regulatory Affairs, Study Director |