Practical guidance on peptide analysis, method development, regulatory expectations, and best practices for researchers.
A practical guide for researchers interpreting purity percentages, related substances, and setting realistic acceptance criteria for research and IND-enabling work.
How high-resolution mass spectrometry ensures your peptide sequence matches the intended design and reliably detects common synthesis errors and modifications.
Key considerations for residual solvent testing in research and clinical-stage peptides according to current ICH Q3C guidelines and best practices.
ICH Q3D elemental impurity requirements and practical guidance for deciding when ICP-MS testing is essential for your peptide research program.
Why endotoxin testing is critical for peptides used in cell-based assays or in vivo studies and how to interpret LAL results.
Recommended analytical package (purity, identity, impurities, metals, endotoxins) and documentation expectations for regulatory submissions.