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.
Our experience team will guide you throughout the method development and validation that will assure you the success for your substance registration. From test item characterization till the analysis of complex mixtures, and volatile compounds.
Our experience includes:
- Analysis of the API concentration in formulations to be used for oral gavage and other administration routes.
- Determination of the purity for Certificate of Analysis (under GLP) of your test item.
- Purity characterization of complex aerosols.
- Determination of vapor concentrations after chemical trapping.
At Vivotecnia, we are continuously increasing the equipment and techniques to offer you the most appropriate chemical analysis for your product:
- Liquid Chromatography coupled to Diode Array Detector (LC-DAD) and Ultraviolet Detector (LC-UV)
- Gas Chromatography coupled to Flame Ionization Detector (GC-FID) and Electron Capture Detector (GC-ECD)
- Gravimetric analysis
- Sample treatment (Liquid-Liquid extraction, Solid phase extraction, derivatization, etc.)
Our team, consisting of a highly qualified senior study director and technicians with wide expertise will be happy to help you with any inquiry for your substances.
Guidelines and interesting literature
- ICH Q2(R1) “Validation of Analytical Procedures: Text and Methodology”. November 2005
- IUPAC “Harmonized Guidelines for Single-Laboratory Validation of Methods and Analysis”. Pure Appl Chem 2002;74(5).
- Eurachem “The Fitness for Purpose of analytical Methods. 1998
- Lee Whitmire, M. et al. “A Global GLP Approach to Formulation Analysis Method Validation and Sample Analysis”. Pharm Anal Acta 2011;S2
- Lee Whitmire, M. et al. “NonClinical Dose Formulation Analysis Method Validation and Sample Analysis”. The AAPS Journal 2010;2(4)