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LC-MS Approaches to Profiling of Non-Radiolabelled Metabolites in Response to Recent Regulatory Changes

LC-MS Approaches to Profiling of Non-Radiolabelled Metabolites in Response to Recent Regulatory Changes content piece image
The key aims of these regulatory guidelines are to:

■ Identify unique human metabolites
■ Characterise disproportionate human metabolites
■ Assess relative exposure of parent drug and its metabolites

LC-MS approaches have become the methods of choice for these investigations. Identification and characterisation of metabolites relies on locating metabolites within a complex matrix and may be addressed using the performance of modern accurate mass instruments such as the Thermo LTQ Orbitrap.