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PHARMACEUTICAL ANALYSIS Our Client is a GLP-compliant contract research organisation established in 1989, employing nearly fifty scientists. Our client specialises in residue analysis including independent laboratory validations and method development, animal transfer studies, agrochemical product analysis, ecotoxicology and pharmaceutical analysis. Our client's experience in agrochemicals is extensive and includes field residues, dissipation studies, analytical sciences, environmental sciences, product chemistry, operator exposure, dislodgeable foliar residues and re-entry studies. Our client's team is very experienced and enthusiastic and has a successful track record of generating quality data on time. Section Capabilities The Pharmaceutical Section works in compliance with GLP and undertakes work regarding pharmaceuticals and veterinary medicines to current ICH and VICH guidelines. Services Offered: - Active Ingredient Content.
- Related Substances Content.
- Impurity Content.
- Residual Solvent Analysis.
- Uniformity of Content.
- QC release, Certificates of Analysis.
- Dissolution Testing.
- Disintegration Testing.
- Pharmacopoeia Testing, Raw Material Analysis.
- Range of Physical Testing.
- Method Development and Validation.
- Method Transfer/Cross-Validation.
- Photostability Testing.
- Storage Stability Trials to current ICH Guidelines (storage cabinets at 25C/60% RH, 30C/60% RH, 30C/65% RH, 40C/75% RH, and additionally a range of temperature controlled storage at ambient humidity).
- Accelerated and long-term stability testing using a range of temperature controlled storage.
Continuous computer monitoring of all temperature and humidity storage locations. Equipment Available: - HPLC (UV/Vis, DAD, EC, RI, fluorescence) isocratic and gradient
- GC (FID, FPD, NPD, ECD)
- GC Headspace Sampler
- GC-MS (EI and CI modes)
- LC-MS/MS (3 x API 4000)
- Chromatographic data acquisition, processing and retention through Agilent
- ChemstationTM, Agilent ChemstoreTM, and PE Sciex AnalystTM (LC-MS/MS) software
- UV/Vis spectroscopy
- TLC
- Polarimetery
- Melting Point Apparatus
- Viscometers (cone and plate, spindle)
- Density Meter
- Karl Fischer Titrators
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