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Analytical R & D, ensures all processes and products transferred to manufacturing operations meet regulatory guidelines.
They ensure the development and validation of the right testing methods and systems are in line with regulatory expectations including detection, identification & quantification of trace levels of genotoxic impurities.
Lupin’s Analytical Research Lab is fully automated and equipped with state-of-the-art technology and instrumentation, for example, equipment like,
– Powder X-ray Diffraction,
– Solid State NMR and
– Differential Scanning Calorimetry to study physical properties such as polymorphism
– Latest LC/MS-MS systems and
– Automated preparative HPLCs for the isolation/synthesis and characterization of impurities in APIs and drug products