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Identifying impurities in a manufacturing process is critical for its optimization and also to support regulatory filing. With advanced analytical tools and rigorous quality control with our state-of-the-art chromatographic, mass spectrometry and nuclear magnetic resonance instrumentation, we can unambiguously determine the structure of impurities and propose a mechanistic understanding regarding their formation.
Impurities are often formed at minute levels, which may hamper their direct identification. While forced degradation may help increase their level, complete isolation may be required for full characterization. We have developed a workflow for us to rapidly increase titers and monitor the impurities to allow their isolation.
Analyses are typically carried out by LC-MS, MS-MS fragmentation techniques for complex molecules, or gas chromatography when dealing with volatile and semi-volatile compounds. We can also use MALDI technology for larger molecules. With our NMR machines, we obtain a complete visualization of the molecule in terms of connectivity and stereochemistry.
The ultimate proof of identity will be derived by preparing an authentic sample of the impurities. This will confirm our understanding of its formation and optimization directions for the process to avoid it. The authentic samples will also serve as a reference standard, to help enhance chemical and pharmaceutical manufacturing processes and optimize product quality.
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