Peptide Characterization

Introduction Ion Mobility Mass Spectrometry enables the resolution of co-eluting isomeric peptide impurities by distinguishing gas-phase peptide ions according to […]

Introduction: D-Amino Acid Impurity Analysis in Peptides is the set of analytical procedures used to detect, locate, and quantify unwanted

Introduction Analytical Characterization for 505(b)(2) Peptide Products provides the comprehensive physicochemical, structural, and functional profile required to establish product safety,

Introduction Peptide-Drug Conjugate (PDC) Characterization Services deliver specialized analytical testing that uses high-resolution mass spectrometry and liquid chromatography to confirm

Introduction The execution of GMP Release and ICH Stability Testing establishes the comprehensive analytical framework necessary to demonstrate that therapeutic

Introduction Counter-Ion Analysis Services for Peptide APIs provide essential quantitative determinations of non-peptidic ionic species—specifically trifluoroacetate (TFA), acetate, and chloride—that

Introduction Quantitative characterization of active pharmaceutical ingredients (APIs) requires accurate differentiation between total lyophilized mass and the true active drug

Introduction Peptide characterization data produced by a Contract Research Organization (CRO) may be submitted to the U.S. Food and Drug

Introduction From a characterization perspective, synthetic vs recombinant peptide drug characterization differs primarily in the assessment of process-related impurity profiles,

Introduction Charge Variant Profiling by icIEF identified a critical comparability failure in an adalimumab biosimilar candidate by detecting an unacceptable