Formulations (dietary, gavage, inhalation, parenteral, and topical) are analyzed to determine the concentration of test material using a variety of chromatographic and spectroscopic techniques. In addition, we offer analytical services in support of inhalation toxicology studies, including determination of particle size distribution, analysis of inhalation blends for confirmation of homogeneity and concentration, and analysis of inhalation chamber atmospheres.
From point of receipt, test articles are stored and handled by trained staff in dedicated formulation facilities. Full accountability of the test articles are maintained though their storage, use, distribution and disposition. We are experienced in the preparation of preclinical formulations suited to dosing all species and in vitro systems. Formulation types include gavage, parenteral, dietary, inhalation, and topical and have a wide range of formulation equipment suited to these needs. Procedures are designed to prevent cross contamination from one test article to another and also from test article to control article. Some sites are now operating Dispense to assist in the identification, accountability, and formulation of test articles.
Methods typically employed include:
Bulk test articles are analyzed for determination of identity, purity, and stability to support GLP preclinical studies. Adhering to strict regulatory guidelines, test article receipt, storage, distribution, use, and disposition are controlled by dedicated staff with several facilities operating a barcode system for identifying and monitoring materials.
- HPLC – High-performance liquid chromatography
- UV-Vis spectroscopy
- CE - Capillary electrophoresis
- GC - Gas chromatography
- GC/MS – Gas chromatography/mass spectrometry
- LC/MS/MS – Liquid chromatography/mass spectrometry
- AAS - Atomic absorption spectrophotometry
- FTIR – Fourier transform infrared spectroscopy
- Karl Fischer