BOC Sciences provides general analysis and purification services for the clients from candidates discovering to clinical trial chemicals. Related date is provided by our analytical team throughout the development process. Our cGMP analytical laboratories facilitate integrated and efficient project support with scientific analysists actively engaging with clients and providing analyses to Formulations and Manufacturing departments.
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The majority of compounds contain certain amount of impurities and will suffer from a certain extent of degradation during production, storage and transportation. Recognizing the fact that it is inadvisable and costlier to replace these compounds just by re-synthesis or purchasing, utilizing purification techniques or chemical transformations to reclaim the pure compounds, therefore, represents an alternative approaches that is more efficient and rapid.
Although the optical isomers in a chiral compound have the same physical and chemical characteristics in general, they will exhibit marked differences in the pharmacological and toxicological activities. Chiral separation and analysis of racemic drugs is therefore of great importance in the pharmaceutical and chemical industry.
As one of the most key elements for any pharmaceutical development program, analytic method development, validation, and transfer play an essential role in many aspects such as controlling the quality, insuring the safety and improving the potency of products. These activities are interrelated and iterative particularly during early drug development phases.
Our analysis platform is based on the current instrument requirements. Special instruments are used for qualitative analysis, quantitative analysis and morphological analysis.
| 1H-NMR |
13C-NMR | |
2D-NMR | |
| Preparative HPLC |
Analytical HPLC | |
Chiral HPLC | |
| HRMS |
GC and GC-MS | |
LC-MS | |
| FTIR |
UV-Vis | |
Polarimeter | |
Karl Fischer titration test | |
Elemental analyzer | |
X-ray powder Crystal Diffractometer |
Strict adherence to ICH and cGMP guidelines
Continuity in analytical work-training and transfer of analytical methods to Quality Control
Engagement in project management throughout the development process
Development of robust and easily transferrable methods