Peptide Characterization

Typical sample requirements are discussed during project scoping. For intact mass analysis, as little as 10–50 µg may suffice, while peptide mapping generally requires 50–100 µg. Exact amounts depend on peptide complexity and number of analyses.

We employ multiple orthogonal proteases (trypsin, chymotrypsin, pepsin) to maximize coverage, along with chemical cleavage if needed. For cyclic peptides, non-reduced mapping with alternative digestion protocols is used. The exact strategy is tailored per project.

Yes. Our reports are structured to align with ICH Q6B and FDA guidance for peptide characterization. Deliverables include raw data, method descriptions, impurity tables, and a Certificate of Analysis. Additional regulatory gap analysis can be included as scoped.

Yes. Our LC-MS/MS workflows are designed to identify and localize modifications including oxidation, deamidation, acetylation, glycation, and d-amino acid isomerization. Quantitation is performed using extracted ion chromatograms or targeted MS/MS.

Project timelines are established during the scoping meeting after reviewing sample complexity and the number of assays. Typical durations range from a few weeks to several weeks depending on scope. Please contact us for a timeline estimate.

Yes. Forced degradation studies (acid/base, oxidative, thermal, photolytic) can be included as part of the characterization package. Long-term stability monitoring is scoped per project. All stability-indicating methods are qualified before use.