Cosmetics & OTC Stability Testing | 101 Guide

Commonly asked questions about “stability” or “shelf-life” projects/studies for cosmetics.

Which products need stability testing?
Cosmetic or OTC brands with Expiration dates or “Use by” dates on packaging.
What does “stability” mean?
A process used to check how long a cosmetic or OTC product stays safe, effective, and unchanged in quality, when stored under different conditions.
Why do I need stability testing for my product?
Stability testing in cosmetics or OTC products ensures the product stays safe, effective, and unchanged throughout its shelf life, so consumers can use it confidently until it expires.
When are stability projects typically done?
Stability studies are typically performed before launching a new cosmetic or OTC product, when there are changes to the formula, packaging, or manufacturing process, and when expanding to new distribution channels or storage conditions.
Where is stability testing performed?
At ISO 17025-accredited laboratories with calibrated stability chambers and scientists who are experienced in designing and conducting testing protocols aligned with ICH storage conditions. Certified Laboratories meets these requirements and offers stability testing services.
How does stability testing determine shelf-life or use-by dates?
By providing data that allow your company to understand how the product behaves in various storage conditions over pre-set periods of time. If the product remains within your specifications during the time, you can confidently set its shelf-life or use-by date for consumer use.

Ready for more? Our Cosmetics, OTC, & Supplements Resource Library contains more resources on cosmetics and OTC drug stability testing:

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