Products:
- Cosmetics
- Over-the-Counter (OTC)
- Cosmetic-OTC Crossovers
- Personal Care Products
- Dietary Supplements
Our Cheat Sheet helps you…
- Determine if your product requires stability testing for regulatory purposes.
- Understand allowable product claims.
- Discover important U.S. regulations.
- Find out what you need to know to begin a stability testing protocol.
Jumpstart Your
Stability Program
Jumpstart Your
Stability Program
All Your Stability Testing Needs Covered
Certified Laboratories offers stability testing based on ICH, FDA, USP, EP, and ISO regulations for cosmetics, OTC, personal care products, dietary supplements, cannabis products, and more. With more than 90 stability testing chambers available, we provide a full range of stability testing conditions based on ICH guidelines for long-term, intermediate, accelerated, and photostability conditions to support your shelf-life claims, expiration claims, and period-after-opening (PAO) claims.
Available Services
- Active Ingredient Assays by HPLC, GC, and other Analyses
- Antimicrobial Effectiveness/PET
- Microbial Limits
- Moisture/Solids
- BP, EP, JP, and USP Monographs Tests
- Color, Odor, and Appearance
- pH
- Specific Gravity
- Viscosity
- Package Compatibility
- Hardness
- Weight Loss/Gain
- Period-After-Opening
- Freeze/Thaw Analysis
- Ambient/Above Ambient
- Photostability
- UV
ICH Storage Conditions
- 25°C ± 2°C/60%RH ± 5%RH
- 40°C ± 2°C/75%RH ± 5%RH
- 30°C ± 2°C/65%RH ± 5%RH
- 30°C ± 2°C/75%RH ± 5%RH
- 45°C ± 2°C
- 50°C ± 2°C
- 60°C ± 2°C
- 5°C ± 2°C (Refrigerator)
- UV
- Photostability [per ICH Q1B guidelines, option 2 (1.2 million lux – hour/200 W/M²)]
- Freeze/thaw (-10°C to -20°C)
- Ambient/Above Ambient