SOP Guide for Pharma

SOP for Conducting Physical Stability Studies on Emulsions

SOP for Conducting Physical Stability Studies on Emulsions

Conducting Physical Stability Studies on Emulsions

1) Purpose

The purpose of this SOP is to describe the process for conducting physical stability studies on emulsions. Physical stability is essential to ensure that emulsions maintain their homogeneity, droplet size distribution, and absence of phase separation over time under various storage conditions. This helps establish the shelf life and suitability of emulsions for commercial or clinical use.

2) Scope

This SOP applies to personnel involved in the formulation, testing, and quality control of emulsion-based products. It covers the preparation, evaluation, and testing of emulsions to monitor droplet size distribution, zeta potential, viscosity, and visual signs of instability such as creaming, coalescence, or phase separation.

3) Responsibilities

4) Procedure

4.1 Preparation for Stability Testing

4.2 Key Parameters for Physical Stability

The following parameters must be monitored during physical stability studies:

4.3 Sampling and Testing Time Points

4.4 Data Recording and Analysis

4.5 Stability Criteria

The emulsion is considered physically stable if it meets the following criteria throughout the stability study:

5) Abbreviations, if any

6) Documents, if any

7) References, if any

8) SOP Version

Version 1.0

Annexure

Annexure 1: Stability Test Report Template

Time Point Storage Condition Droplet Size (nm) Zeta Potential (mV) Viscosity (cP) Visual Inspection Operator Initials
Initial 4°C 100-200 nm -30 to -50 mV 10 cP No creaming Operator Name
1 Month 25°C 100-200 nm -30 to -50 mV 10 cP No creaming Operator Name
3 Months 40°C 100-200 nm -30 to -50 mV 10 cP No creaming Operator Name
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