Dose Formulation Analysis

Dose Formulation Analysis

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.


GLP Formulation Method Validation

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:

  • Evaluate the homogeneity and stability of the formulation to cover the expected conditions during preparation, storage, dosing, and shipment
  • Discover any issues with solubility and stability prior to the start of toxicology studies
  • Verify ligand-binding functional activity for antibody biologics

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.

GLP-compliant Certificate of Analysis (COA) Generation

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.

  • Preclinical dose confirmation analysis for GLP toxicology studies
  • Method development and validation using LC/MS/MS, HPLC/UV, or¬†Immunoassay
  • Formulation sample analysis to assess stability, homogeneity, and to discover solubility issues

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