Chemical analysis of the test item and/or Active Pharmaceutical Ingredient is essential to determine the actual dose in in-vivo studies. To this aim, Vivotecnia can offer you the analytical method development and GLP validation to complete your toxicology studies.
A fully GLP validated method needs to be used for:
- Formulation analysis: The accuracy, homogeneity and stability of the formulations prepared for in-vivo studies is crucial to assure the correct and uniform administration. This test is usually performed before the use in test systems and at different stages during long-term studies. Samples from the different formulation solutions prepared are analysed to evaluate it is within acceptability criteria.
- Aerosol concentration analysis for inhalation studies: The determination of the aerosol concentration is required for all kind of inhalation toxicology studies, i.e. from acute (OECD 436 and 403) to subchronic studies (OECD 413). The determination can be performed gravimetrically by collecting the aerosol in an appropriate filter only if a pure solid or liquid test item is used. For aerosols generated from non-pure solid or liquid test items (such as formulations or mixtures) as well as vapors (highly volatile liquids) or gases, a selective analytical method is required. Typically, by chromatography.
At Vivotecnia, we have the experience to guide you and complete your in-vivo studies with in-house chemical analysis. Why in-house? By placing the chemical analysis at Vivotecnia, you will gain flexibility (changing vehicle, concentrations and/or preparation protocol) as well as avoid stability issues due to sample shipment.