Dose Formulation Analysis
Ricerca scientists use nonclinical dose formulation analysis methods to confirm API concentration and homogeneity in test formulations and to determine formulation stability in support of regulated nonclinical studies. Utilizing HPLC/UV, LC-MS/MS or ELISA methods, Ricerca can quickly develop and validate GLP and non-GLP methods for the analysis of drug content in liquid and other formulations. In addition to homogeneity and stability, we evaluate the performance of the method as well as the compound’s ability to withstand expected conditions during preparation, storage, dosing and shipment. This method also allows cross-validation for new formulation matrices.
Using analyses such as purity, water content, mass confirmation, etc., Ricerca analytical chemists can generate an audited certificate of analysis detailing the Active Pharmaceutical Ingredients (API), metabolites or internal standards for regulatory submission.