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Lubaq Corporate
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When bringing a product to market, regulatory approval requires the isolation and characterization of structures for all impurities exceeding certain concentration (normally 0,1%) in the technical material. Very often, the impurities belong to the same family of substances as the main component. The close structural similarity of the impurities and their low natural concentration add up to the difficulty of such projects.
Service Outline
Impurity screening in technical materials.
Isolation of low level impurities in quantities sufficient for structural elucidation and for the required study
Ability to resolve and isolate CHIRAL components
Method validation
Specialization in isolation of closely related synthetic products
Milligram to multi-gram orders
Structural elucidation, component identification and documentation of impurities
Isolation of highly-labile compounds
Impurity Isolation
Lubaq has preparative equipment with multiple modes of separation, including normal and reverse phase High Performance Liquid Chromatography (HPLC) to enable isolation of materials, as necessary. The Lubaq team has many years of experience with these techniques to enable rapid isolation in the most efficient possible manner.
Materials of Interest Include (for example):
reaction side products produced during process development and scale up
impurities formed during stability studies via API degradation or reaction with excipients
metabolites of APIs observed during clinical testing
Purification for structural Elucidation
The Lubaq team ensures the accurate characterization of tarjet compounds using the cutting-edge instrumentation in high resolution mass spectrometry and NMR.
