Dose Formulation Analysis

Preclinical Dose Formulation Analysis for GLP and non-GLP Studies

Dose confirmation analysis for 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. We provide high quality, preclinical dose formulation analysis for both GLP and non-GLP studies, to ensure your study starts off on the right track.

GLP Formulation Method Validation

We quickly develop and validate LC/MS, HPLC/UV, or immunospecific 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.

Our analytical approach to dose 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

We’ll 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.

Equipment and Software for Dose Formulation Analysis

BioAgilytix has invested in new UPLC systems for dose formulation analysis and built out a separate lab space to isolate these high concentration samples from the sub nanogram level bioanalytical samples. The new UPLC systems have UV/VIS, diode array, CAD (Charged Aerosol Detection), and fluorescence detection capabilities.

Featured Case Study

Simultaneous Determination of Drug Concentrations

Learn how the development of a novel extraction and derivatization scheme allowed us to simultaneously determine free and covalently bound drug concentrations using a single assay.

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