Stability testing and study
The 6NAPSE Group laboratories supports you in the stability testing of your product and in its compliance.
Why carry out stability testing ?
The stability study of a pharmaceutical or cosmetic product is essential during its development or validation. Indeed, despite changes in environments, the product must remain stable and retain its physical and chemical properties.
If for any reason (temperature change) a factor creates a structural change, it may lose performance.
The objective of a stability study is to understand how the product will evolve under previously established conditions over a specific period of time, and to study its evolution (effectiveness, chemical composition, crystallography, etc.).
Stability study laboratory
The 6NAPSE Group laboratories offer product stability studies and testing. Our teams observe the aging of products over time and the storage conditions of the products.
Initially, the laboratory stores products in ICH enclosures at controlled temperature and humidity with a determined profile. We can also carry out a “photo stability” study, which consists of checking the light stability of products and packaging.
Secondly, the laboratory studies the physicochemical behavior of the material to see if the product changes over time (by following different batches over time, up to 3 years).
- Observation of the evolution of crystallography (XRD)
- Study of the zeta potential for product stability (nanoparticle analysis)
- Study of phase change and chemical composition (DSC, infrared spectrometry, Raman spectrometry)
- Visual inspection and characterization of the texture, appearance and adhesion of the material (glossmetry, colorimetry, standardized adhesion test, etc.)
- Determination of leachables (ICP-AES, ICP-MS, GC-MS)
Pharmaceutical product stability study
- Stability study according to the ICH standard (ICH Q3C and ICH Q3D)
- Stress study to verify the container-content interaction between a glass bottle and a pharmaceutical product
- Definition of the storage conditions of the medicine according to its environment
- Analysis of active ingredients (API)
- Drug analysis
- Stability study of products from the pharmacy or parapharmacy
- Photo-stability study of pharmaceutical products
Cosmetic product stability study
- Stability study of sunscreens, lotions and care creams
- Product stability testing to verify product stability and antimicrobial effectiveness (as part of formula development / R&D)
- Study of the light stability of cosmetics and packaging
6NAPSE Group assets
- Complete validation plan (support for all tests of a standard)
- All controls, tests and analyzes in our laboratories are carried out in compliance with the quality criteria of our industrial customers.
- Short standard deadlines and emergency support options
Contact us to discuss your needs quickly and technically!