Pharmaceuticals and Veterinary Medicines Service

Section Capabilities

The Pharmaceutical Section works in compliance with GMP and 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 25°C/60% RH, 30°C/65% RH, 40°C/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 - three SCIEX API 4000, one with a QTRAP, one with Spark-Holland SymbosisTM Pharma, plus one SCIEX API 5000
• 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