Carbon-14 ( C)-labelled active pharmaceutical ingredients (APIs) and investigational medicinal products (IMPs) are required for phase 0/I to phase III mass balance and micro-dosing clinical trials. In some cases, this may involve the synthesis of C-labelled peptides, and the analysis can be performed by accelerated mass spectrometry (AMS). The C-peptide is typically prepared by the solid-phase peptide synthesis (SPPS) approach using custom-made glassware for the key coupling steps. Further modification of the purified C-peptide can then be performed.
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http://dx.doi.org/10.1002/jlcr.3777 | DOI Listing |
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