Custom Peptide Synthesis
Peptide CMC
Catalog Peptides
cGMP Peptide APIs Manufacturing
Analytical development
Service overview
Biopeptek has a dedicated peptide analytical team of 70+ scientists with extensive experience and expertise to support
all peptide analysis at all development phases. Our analytical service will streamline your peptide development with
customized, flexible, and integrated analytical solutions.
Our services included
Method development and validation
Stability study: forced degradation study, accelerated and long-term stability study under R&D and GMP environment
Purity and Assay, residual solvents, moisture, cation content, anion content, aggregation content, elemental impurities
Microbiology safety: endotoxin for limit and quantitation and bioburden for microbial limit test
Amino acid analysis and enantiomeric purity: acid hydrolysis and derivatization followed by LC-MS analysis to accurately
evaluate the amino acid ratio and D-isomer impurity amount in the peptide sequence
Identity by peptide mapping: enzymatic digestion followed by LC-MS analysis for characterization and confirmation of peptide API
Analytical capability
- Appearance
- Solubility
- Peptide purity (HPLC)
- Related substances (HPLC)
- Molecular weight (MS)
- Peptide content
- Amino Acid Analysis
- Counterion content
- Moisture content (Karl Fisher)
- Residual Trifluoroacetic acid
- Residual organic solvents
- Bioburden
- Endotoxin
