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Analytical Chemistry Services

The Analytical Chemistry Department at WIL Research Laboratories, LLC provides dose formulation analysis services for the pharmaceutical, biotechnology, agrochemical, and chemical industries to support a wide range of toxicity studies conducted in compliance with the Good Laboratory Practices (GLP). The Analytical Chemistry Department has experience with the analysis of small organic compounds, peptides and proteins, polymers, and metals in a variety of vehicles and carriers. Our analytical services provide the data to support claims of uniformity, stability, purity and concentration for worldwide regulatory submissions.

Expertise

Our experienced professional analytical chemists work closely with a highly qualified technical staff to provide rapid method development and thorough, GLP-compliant method validations. Activities are performed as separate studies with a chemist serving as study director, or in conjunction with a toxicology study director. Either way, the result is precise, accurate, and high quality data.

Timeliness

Whether transferring a client’s analytical method or developing a novel method, we use a solid, scientific approach to identify solutions and meet timelines. Our routine analyses are performed in conjunction with study schedules to provide study directors with the data they need, when they need it.

General Capabilities

• Method Development: WIL’s expert analytical chemists have developed hundreds of methods specific to our study sponsor’s needs.
• Method Validation: Our approach to method validation ensures long-term success for the method and addresses all essential factors – calibration reproducibility, accuracy, precision, stability, specificity, and ruggedness.
• Routine Analysis: Homogeneity, stability and concentration assessments of dosing formulations. Acceptance of results is defined by pre-established criteria.
• Purity Assays: Confirmation of test article stability during the course of a study.

Instrumentation

All instruments are fully automated and software systems have been validated in accordance with a rigorous facility validation program that meets GLP and Part 11 requirements.

• HPLC Systems: variable wavelength, diode array, fluorescence, refractive index, and electrochemical detectors
• HP/Agilent 1100
• HP 1050
• Dionex Summit
• Dionex 3000
• ESA Coularray
• Variable wavelength, diode array, fluorescence, refractive index, and electrochemical detectors
• Ion Chromatograph
• Dionex ICS-2000
• Gas Chromatographs: flame ionization, flame photometric, electro-conductivity, nitrogen-phosphorus, and mass selective detectors
• HP 5890
• HP/Agilent 6890
• Spectroscopy
• Cary 100 UV/visible spectrophotometer
• Molecular Devices SpectraMax 190 UV/visible spectrophotometer
• PE AA800 atomic absorption spectrometer with flame and graphite furnace
• Mass Spectrometers

Facilities

Our facility has undergone an extensive validation to ensure proper operation and compliance with GLP requirements.

• State-of-the-Art Laboratory Complex – over 28,000 sq. ft.
• 100% fresh air to reduce concerns with airborne contamination
• Large sample preparation lab – over 2,350 sq. ft.
• Custom-designed instrument laboratory – over 3650 sq. ft. for chromatography and mass spectrometry
• Separate room for storing and weighing test articles and standards
• Elemental analysis laboratory
• Isolated rooms for special analyses