GMP Peptide

GL Biochem manufactures GMP grade peptides under strict adherence to  Good Manufacturing Practices.

  GMP Peptide Technology Platform

  • Raw material qualification
  • Synthetic method development, validation and scale up
  • Product Purification
  • GMP/GLP analytic method development and validation
  • Release specification design and testing
  • Stability testing (if needed)
  • GMP packaging
  • GMP compliance documentation
     

   GMP compliance

  • On-going training
  • In-house Audit
  • Raw material control
  • Analytical method validation and documentation
  • SOPs
  • In process control and batch record
  • Equipments
  • Computers

 

   Certificate of Analysis for GMP Peptide

 

  • Appearance
  • Purity by HPLC
  • Heavy metal by ICP-MS
  • Bioburden or microbial tests
  • Residual organic solvent by GC

 

  • Solubility
  • Molecular Weight by MS
  • Amino acid analysis
  • Water content
  • Endotoxin
  • Amino acid analysis
  • Peptide Content (nitrogen estimation)
  • Counter Ion Content (% TFA) by IC