Shelf-Life Stability – (ICH Q1A, Q1B, Q1C, Q5C)

  • Storage Stability Studies (ICH Storage Conditions) – Storage stability testing serves your cosmetic product by gauging its chemical integrity or potency over time. Our stability chambers are validated per FDA and ICH guidelines (Q1A, Q1B, Q1C, Q5C) and we employ custom set points and chamber configurations to fit your needs. GLP documentation is used to track your product’s data throughout the entirety of testing.
    • 25°C / 60% RH
    • 30°C / 65% RH
    • 40°C / 75% RH
    • 2°C – 8°C
    • -20°C
    • ICH Photostability, Option I
  • Challenge Tests –  Forced degradation of your cosmetic product is used to generate samples representing the effect of time and other factors on its many properties. Avazyme achieves various levels of degradation by exposing your product to physical pressure, UV light, pH, and temperature. Stability is indicated by the amount of active ingredient and degradation products as measured by GCMS or LCMS.

Adulterant and Contaminant Testing – Manufacturing processes can naturally result in the production of substances other than the intended product. Such impurities can come from process contaminants, API and non-active component degradation, leachables, unreacted monomers/oligomers, and oxidized additives. We typically measure less volatile impurities with LC-MS e.g., pesticides, PFAS. We test more volatile impurities with GC-MS and HS-GC-MS, e.g., residual solvents, terpenes. Upon isolating your impurity, we have the capacity to perform further MS, NMR, ICP, or other specialized investigations.

In the case of natural product derived APIs we can assist with analytical methods and investigations of interactions with other ingredients in the formulated end product. Contact us for a more detailed discussion.

Pathogen screens – Microbial contaminants in cosmetics are of growing concern for human health and storage stability reasons. Avazyme uses enrichment culturing and colony counting to test for the following pathogens, among others: Salmonella spp., Listeria monocytogenes & Listeria spp., Bacillus cereus enterotoxin, E.coli  O157:H7 & Escherichia & coliform spp., Staphylococcus aureus, yeast and mold, Vibrio cholerae & Vibrio spp., and Enterobacteriaceae.