Determine Your Product's Shelf-Life
What is shelf life?
This date refers to the length of time a product may be stored under recommended conditions before it becomes unfit for use, consumption, or sale.
What factors affect shelf life?
-
Unwanted microbial contamination
-
Oxidation
-
Acidity (pH)
-
Available water for microbial growth (water activity)
-
Emulsification stability
-
Preservative system
-
Temperature
-
Light
-
Packaging material
-
Storage conditions
-
Transportation
-
Etc.
Why is determining shelf life important?
Not only can degradation impact your brand reputation, but consumers expect the products they are using to be safe for consumer use. To be in compliance, it is imperative that your product as the most accurate expiration date as possible, to prevent any consumer illnesses and potential lawsuits. Additionally, many distributors will require you provide accredited 3rd party stability testing results in order to carry a specific product.
Shelf-Life Studies By Industry:
Cosmetics & Personal Care Stability Studies
-
We follow ISO/TR 18811:2018(E) standard to determine stability of cosmetics and personal care products, which states:
-
“Stability studies are aimed at assessing the ability of a product to maintain the desired physical, chemical and microbiological properties, as well as functionality and sensorial properties when stored and used under appropriate conditions by the consumer. More simply, the objective of a stability study is to determine the shelf life of a product and to evaluate whether a product in the package is stable when subjected to the market conditions in which it is sold and used. The “market conditions” encompass distribution (transportation), warehouse storage and conditions during use."
-
​
-
Thus, the stability study may be seen as a prerequisite for ensuring product quality. Stability tests on cosmetic products are required for:
-
Obtaining guidance on the formulation of the product, and the appropriate packaging material.
-
Optimizing the formulation and manufacturing process.
-
Determining conditions of transportation, storage, display and manner of use.
-
Estimating and confirming shelf life and ensuring customer safety.
-
Dietary Supplement Stability Studies
-
Stability studies for dietary supplements are an essential component of current Good Manufacturing Practices (cGMP) and regulatory compliance, ensuring the product's safety, identity, strength, quality, and purity throughout its stated shelf life.
-
The primary objective of a stability study is to assess the ability of a finished supplement product containing vitamins, minerals, or other active ingredients to maintain its label claims, physical characteristics, and safety profile when stored under appropriate environmental conditions (e.g., temperature, humidity).
Focus on Active Ingredient Potency​​
-
Unlike non-active consumer goods, regulatory requirements for dietary supplements place a critical emphasis on potency assurance. The stability program must include testing for all active ingredients and vitamins at each pre-determined time pull (e.g., initial, 3, 6, 9, 12, 18, 24 months, and accelerated points). This robust, time-point-specific chemical analysis is mandatory to monitor and confirm that no significant ingredient degradation occurs over time and that the product meets 100% of its label claim through the final day of its expiration date. This rigorous testing ensures both customer confidence and regulatory adherence.
​
​
Stability Study Benefits​
Executing a comprehensive stability study is a mandatory prerequisite for product quality and regulatory compliance. Stability tests on dietary supplements are required for:​
-
Regulatory Compliance: Meeting cGMP requirements for establishing and confirming a product's shelf life (e.g., 21 CFR Part 111 in the United States).
-
Formulation Guidance: Providing data to guide the selection of excipients and the most protective packaging material to mitigate ingredient degradation.
-
Manufacturing Optimization: Validating that the chosen manufacturing process does not negatively impact the long-term stability or bioavailability of active compounds.
-
Storage and Distribution: Determining the appropriate conditions for storage, transportation, and display to maintain product integrity.
-
Shelf Life Confirmation: Establishing and scientifically confirming the official expiration date, ensuring consumers receive a fully potent and safe product.