Standard Operating Procedure for Elevated Temperature Stability Testing
Document ID: SOP-002
Version: 1.0
Effective Date: ___________
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.
This SOP applies to all cosmetic emulsions during development and quality control phases. Accelerated testing supplements but does not replace real-time stability testing.
| Temperature | Application | Duration |
|---|---|---|
| 37°C (98.6°F) | Standard screening, gentle stress | 8-12 weeks |
| 40°C (104°F) | Most common accelerated condition | 8-12 weeks |
| 45°C (113°F) | Aggressive screening, rapid results | 4-8 weeks |
| Timepoint | Duration | Action |
|---|---|---|
| T0 | Day 0 | Initial evaluation before incubation |
| T1 | 1 Week | Visual check, pH if indicated |
| T2 | 2 Weeks | Full evaluation |
| T3 | 4 Weeks | Full evaluation |
| T4 | 8 Weeks | Full evaluation |
| T5 | 12 Weeks | Final evaluation |
Observe for: phase separation, creaming, sedimentation, oil/water separation, syneresis (water release)
Document: yellowing, browning, fading, color migration
Evaluate: rancidity, chemical notes, fragrance degradation, off-notes
Measure and compare to T0. pH drift may indicate chemical degradation or preservative instability.
Significant thickening or thinning indicates emulsion stress or polymer degradation.
| 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: