LC-MS/MS Identification of Impurities Present in Synthetic Peptide Drugs

The presence of impurities, even at low concentrations, may affect the safety and efficacy of a drug substance (API). For most peptide pharmaceuticals, the API is defined and can be clearly characterised, however the identification of peptide related impurities can be challenging due to their complexity. A correct identification of the impurities is critical for the development and optimisation of the manufacturing process of the API material. Presented here is an example of a synthetic peptide API and related impurities characterisation performed at Almac. The peptide API and impurity sequences were elucidated using accurate mass measurements and MS/MS fragmentation. Using embedded algorithms in the MassHunter Software the accurate mass measurements allowed for the determination of the molecular formula of impurities. MS/MS fragmentation profiling allowed the identification of peptide and impurities sequences including the presence and the location of modifications.

(PDF) LC-MS/MS Identification of Impurities Present in Synthetic Peptide Drugs.. Available from: https://www.researchgate.net/publication/316879317_LC-MSMS_Identification_of_Impurities_Present_in_Synthetic_Peptide_Drugs [accessed Jan 10 2019].