As part of the company's quality management the quality control unit of DOTTIKON EXCLUSIVE SYNTHESIS is responsible for testing raw materials, intermediates and final products to ensure compliance with specifications. For each material an approved testing procedure is available which defines the different analytical methods and their acceptance criteria. The tests are carried out according to cGMP on qualified instruments that were calibrated in defined intervals. Method validation is performed according to the actual ICH guidelines.
The quality control consists of two laboratory teams for chromatographic and none chromatographic methods with overall 10 analysts. Specifications and raw data were maintained in a Laboratory Information and Management System (LIMS).
Main analytical techniques for release tests
- Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Ion Chromatography (IC)
- Capillary Electrophoresis
- Thin Layer Chromatography (TLC)
- IR- and NIR Spectroscopy
- UV/VIS Spectroscopy
- High-Resolution Continuum Source AAS
- Titration (including Karl Fischer)
- Gravimetric Analysis
- Colour measurements
- Melting point
- Loss on drying
- Specific pharmacopoeia tests
Analytical techniques regarding Process Analytical Technology (PAT) Analytical techniques for structure elucidation - Liquid Chromatography with mass spectrometry detection (HPLC-MS)
- Gas Chromatography with mass spectrometry detection (GC-MS)
- NMR (24 hours external service)
More about Quality, click here. >>
|
