In contemporary peptide API manufacturing considerable resources are devoted to development of analytical methods suitable for the detection of impurities.2 While these methods are typically quite adequate for the detection of peptide-related impurities, they may not be equally suited for the detection of minute amounts of low MW non-peptide entities. Nevertheless, small molecule reagents, reactants, solvents as well as amino acid protecting groups can be encountered throughout any peptide API manufacturing process. Incomplete removal of such compounds and/or formation of new small molecules during the manufacturing can compromise the quality of a peptide API.
Jan Pawlas,1 Stefan Hansen, Thomas Svensson and Gunnar Stærkær, EuroPeptides 2012
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