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
Counter-Ion Analysis Services for Peptide APIs: TFA, Acetate and Chloride Quantification Read More »
Introduction Quantitative characterization of active pharmaceutical ingredients (APIs) requires accurate differentiation between total lyophilized mass and the true active drug
Net Peptide Content and Amino Acid Analysis Testing Services for Peptide APIs Read More »
Introduction Peptide characterization data produced by a Contract Research Organization (CRO) may be submitted to the U.S. Food and Drug
Can Peptide Characterization Data Generated by a CRO Be Submitted Directly to the FDA? Read More »
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
Introduction: NMR vs LC-MS for Peptide Characterization is not simply a question of choosing the more advanced instrument — it’s
Introduction: Peptide Impurity Profiling by LC-MS is an advanced analytical approach used to detect and characterize structurally related impurities in
Introduction Charge Variant Analysis of Therapeutic Peptides is a critical analytical framework for profiling, quantifying, and monitoring charged proteoforms and
Introduction Chiral Purity Testing and D-Amino Acid Quantification in a synthetic octapeptide active pharmaceutical ingredient (API) requires high-resolution liquid chromatography
