EN简繁
Request a Compliance Assessment

Standardized service

Cosmetic Stability Test

Accelerated and real-time conditions track changes in appearance, physicochemical, and microbiological indicators over the shelf life, providing the data basis for shelf-life setting, packaging selection, and safety substantiation.

PrerequisiteProduction-consistent samples + target shelf life
TimelineMonths (accelerated); longer real-time
DeliverableReport with shelf-life recommendation
UseShelf-life setting and safety substantiation
On this page

What this service is

Stability testing stores the product under accelerated (elevated temperature, humidity, light) and real-time conditions and periodically examines appearance, odor, pH, viscosity, active content, and microbiological indicators to assess quality over the shelf life.

Stability data underpins shelf-life and period-after-opening setting, verifies formula-packaging fit, and is common supporting material in a MoCRA safety substantiation file.

MoCRA (2022)FD&C Act §608

Who needs it

Cosmetic companies that need to set or verify a shelf life for the U.S. market
Brands confirming shelf-life behavior before launching a new formula
Products reassessing stability after formula, process, or packaging changes

Prerequisites and sequence

  • Provide finished-product samples consistent with mass production, plus your target shelf life.
  • The study design depends on dosage form and packaging; indicators and conditions are confirmed before testing.

Who holds regulatory responsibility

Shelf-life setting rests with the manufacturer. We coordinate the laboratory to design and run the study; you make the final labeled shelf-life decision based on the data.

Materials we need from you

Sufficient finished-product samples (sized to the number of time points)
Complete formula and a brief process description
Packaging format and material details
Target shelf life and storage-condition assumptions

Process

  1. 01

    Define test conditions and indicators based on dosage form and packaging

  2. 02

    Ship samples to the laboratory and place them per the protocol

  3. 03

    Test appearance, physicochemical, and microbiological indicators at each time point

  4. 04

    Aggregate data and evaluate trends

  5. 05

    Issue the stability report with a shelf-life recommendation

Deliverables

Stability test report (with data at each time point)
Shelf-life recommendation
Formula/packaging compatibility conclusion

Timeline

Accelerated studies typically take several months, and real-time studies run longer; the overall schedule follows the confirmed protocol.

Scope

What we provide

  • Study design recommendations
  • Laboratory coordination and progress tracking
  • Data aggregation and report delivery
  • Result interpretation and shelf-life recommendation

What is not included

  • Formula adjustment and retesting after a failed study
  • International sample shipping costs
  • Dedicated period-after-opening (PAO) justification (assessed separately)

Common pitfalls

Labeling a shelf life without dataA labeled shelf life should be backed by stability data, otherwise it is hard to defend in safety substantiation or platform review. New formulas usually start with accelerated studies, with real-time data added over time.
Treating accelerated testing as a full substitute for real-timeAccelerated testing predicts trends quickly; real-time data confirms them. Skipping real-time follow-up leaves the long-term shelf-life conclusion without final confirmation.
Reusing old data after a formula or packaging changeStability conclusions are tied to a specific formula, process, and packaging combination. After any of these changes, the old data no longer applies directly and the need for a new study should be assessed.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Can accelerated testing replace real-time testing?

Accelerated testing predicts trends quickly and is the main basis for setting shelf life; real-time data confirms it. New formulas usually start with accelerated testing, with real-time data added over time.

How does stability relate to packaging compatibility testing?

A stability study already observes the formula in the intended packaging; packaging compatibility testing focuses specifically on interactions between formula and packaging material. The two are often run in the same study.

Can I label a shelf life without stability data?

Not advisable. A labeled shelf life should be backed by data, otherwise it is hard to defend in safety substantiation or platform review.

Related services

Packaging Compatibility TestEvaluates the interaction between formula and packaging over the storage period — whether the packaging deforms or leaks and whether the formula is affected by packaging constituents — providing the basis for packaging selection and shelf-life setting.Preservative Challenge TestStandard organisms are inoculated into the sample and surviving counts are measured at set intervals to verify that the preservative system keeps microbial growth in check over the product's life. Commonly run to USP <51> or ISO 11930, with a report from a partner laboratory.Microbial Limit TestTesting of finished products for total aerobic count, yeast and mold count, and specified objectionable organisms, confirming microbiological quality against U.S. market expectations. Commonly run to USP <61>/<62>.

Disclaimer

Testing is performed by a third-party laboratory; report conclusions apply only to the submitted samples and test conditions. This page is general information.