SOP-002: Accelerated Stability Testing

Standard Operating Procedure for Elevated Temperature Stability Testing

Document ID: SOP-002

Version: 1.0

Effective Date: ___________

1. Purpose

This procedure establishes the protocol for conducting accelerated stability testing on cosmetic emulsions using elevated temperatures. Accelerated testing reveals potential stability issues early in product development and helps predict long-term behavior.

2. Scope

This SOP applies to all cosmetic emulsions during development and quality control phases. Accelerated testing supplements but does not replace real-time stability testing.

3. Temperature Selection

TemperatureApplicationDuration
37°C (98.6°F)Standard screening, gentle stress8-12 weeks
40°C (104°F)Most common accelerated condition8-12 weeks
45°C (113°F)Aggressive screening, rapid results4-8 weeks
Selection Guide: Use 40°C for standard testing. Use 45°C for rapid screening of prototype formulations. Use 37°C for products with heat-sensitive ingredients.

4. Equipment Requirements

5. Sample Requirements

6. Evaluation Schedule

TimepointDurationAction
T0Day 0Initial evaluation before incubation
T11 WeekVisual check, pH if indicated
T22 WeeksFull evaluation
T34 WeeksFull evaluation
T48 WeeksFull evaluation
T512 WeeksFinal evaluation

7. Evaluation Parameters

7.1 Physical Appearance

Observe for: phase separation, creaming, sedimentation, oil/water separation, syneresis (water release)

7.2 Color Changes

Document: yellowing, browning, fading, color migration

7.3 Odor Changes

Evaluate: rancidity, chemical notes, fragrance degradation, off-notes

7.4 pH Drift

Measure and compare to T0. pH drift may indicate chemical degradation or preservative instability.

7.5 Viscosity Changes

Significant thickening or thinning indicates emulsion stress or polymer degradation.

Important: Elevated temperatures do NOT sterilize products. Accelerated testing often reveals preservation weaknesses by accelerating pH drift or other changes that compromise the preservative system.

Accelerated Stability Record Form

Product Name:
Batch/Lot Number:
Test Start Date (T0):
Storage Temperature:☐ 37°C ☐ 40°C ☐ 45°C
Incubator ID:
Timepoint Date Appearance Separation? Color Change? Odor Change? pH Pass/Fail Initials
Initial (T0)
1 Week
2 Weeks
4 Weeks
8 Weeks
12 Weeks

Notes/Observations:

Tested By:
Reviewed By: