Pharmaceutical Analysis
CEMAS carries out a range of GMP-, GCP- or GLP-compliant studies in support of the development or registration of drug substances and formulations for both the human and animal health industry to current ICH and VICH guidelines.
CEMAS has a fully equipped analytical facility to provide support to studies including method development, method validation and sample analysis.
Pharmaceutical services:
Active ingredient/Related substances content
Method development and validation
Method transfer/cross-validation
QC release/Certificates of Analysis
Photostability testing
Storage stability trials to ICH guidelines
Services Offered:
- Active Ingredient Content
- Related Substances/Impurity Content
- Residual Solvent Analysis
- Uniformity of Content
- QC release, Certificates of Analysis
- 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 cabinets/rooms
- 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 - four SCIEX API 4000, one with a QTRAP, three with Spark-Holland SymbosisTM Pharma, plus two SCIEX API 5500
- Chromatographic data acquisition, processing and retention through Agilent ChemstationTM, Agilent ChemstoreTM, and PE Sciex AnalystTM (LC-MS/MS) software
- UV/Vis spectroscopy
- TLC
- Melting Point Apparatus
- Viscometers (cone and plate, spindle)
- Density Meter
- Karl Fischer Titrators