Dose confirmation analysis of formulation samples is an important part of any successful GLP study and is required by the United States Food and Drug Administration (USFDA) for formulations dosed in toxicology studies.
At MicroConstants, we provide high quality analysis of preclinical dose formulations for both GLP and non-GLP studies to ensure your study starts off on the right track.
MicroConstants quickly develops and validates LC/MS/MS, HPLC/UV, or ELISA methods for the analysis of drug content in liquid formulations. During method validation, we will:
Our analytical approach to formulation method validation allows quick cross-validation of our assays for new formulation matrices, salt forms, and concentration ranges, thus saving time and money if the formulation requires changes.
MicroConstants will generate an audited Certificate of Analysis (COA) for Active Pharmaceutical Ingredients (API), metabolites, or internal standards. Analyses include HPLC purity, water content, mass confirmation, and other tests as applicable. Simply provide us with a reference standard and list of desired analyses, or an old COA, and we will issue an audited Certificate of Analysis for use in your GLP studies.