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

  • Storage Stability Studies (ICH Storage Conditions) – Storage stability testing serves your 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 veterinary 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.
  • Reconstitution and/or Compatibility Studies – Avazyme quantifies the interactions between your veterinary product and its excipients through techniques including NMR, various types of chromatography, and thermal techniques, among others. We measure physical and chemical compatibility by looking for changes in form, color, dissolution, hydrolysis, oxidation, reduction, precipitation, decarboxylation, and racemization.

Nutritional Equivalency – Veterinary products of different types can often contain approximately equivalent levels of certain nutrients, and this information is useful for creating product-to-product comparisons. Avazyme uses quantitative chromatographic methods to determine the nutritional content of your product and cross references our archive of nutritional analyses to determine any nutritional equivalencies involving your product.

Adulterants and Contaminants – 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 and more volatile impurities with GC-MS, as the absence of a proper mobile phase can allow for a more accurate structural evaluation in some cases. Upon isolating your impurity, we have the capacity to perform further MS, NMR, ICP, or other specialized investigations.

Pesticide Residue Screens – Avazyme offers both a comprehensive pesticide residue screen as well as a customized USDA Organic pesticide residue screen, both of which are performed using LC-MS.

Residual Solvent Levels (by GC/MS) – Determining toxicity is the primary reason for measuring the residual solvents present in veterinary products. Avazyme uses a GC Limit Test to detect classes 1 and 2 of residual solvents, while class 3 residual solvents are detected using a separate LOD test. Quantitative data is acquired through further chromatographic analysis (GC/MS and LC/MS).