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Analytical Services

The Analytical Laboratory offers a variety of services:

HPLC Method Development and Validation

Our Senior Chemists are experienced developers of HPLC analytical assay methods with various columns (reversed phase, ion chromatography, and size exclusion) with UV and reflective index detectors for pharmaceutical compounds with or without chromophores.

Degradation Studies

Conduct stressed sample degradation studies to determine potential degradants and impurity profiles. Identification using diode array analysis of peak purity to develop a stability indicating chromatographic method.

Dissolution Method Development

Develop and perform dissolution profile studies for immediate release and extended release finished products (tablets and capsules) in various media and pH buffer solutions such as SIF, SGF, acetate. BioKey, Inc. is expert in the development of media with various surfactants for pharmaceutical products insoluble in water.

Cleaning Validation

Develop and validate very sensitive methods for swab samples and HPLC, or rinse samples and Total Organic Carbon (TOC) to verify the cleaning of pharmaceutical equipment.

Raw Material Testing
Perform identification of incoming materials (API, excipients, and raw materials) using FT-IR.

Conduct basic physical/chemical testing according to USP methods such as pH, turbidity, density, solubility profile over pH range, melting point, loss on drying, loss on ignition, viscosity and conductivity testing.