Quality control

Analytical development for Phase I and II clinical trials material, and validation for Phase III material, are part of the GMP Quality systems to support releasing of the API.  For purity determination, we typically perform analytical development at an early stage for any project in order to avoid potentially discovering new impurities at a later stage of product manufacturing.

Our Provisional GMP Testing Procedures and Specifications include the following :

  • Appearance – White to Off white powder
  • Solubility – clear solution of a pre-specified concentration (optional)
  • Identity – correct molecular weight, correct sequence and composition by MS/MS sequencing
  • Amino acid composition and Chiral purity (optional)
  • Peptide purity (UHPLC) – 95-98% tailored to product stage and requirements
  • Related substances (UHPLC) – 2-5% tailored to product stage and requirements
  • Assay (peptide content) –  >75%
  • Counterion content – product dependent (typically acetate)
  • Moisture content – <10%
  • Mass balance – 95-105% (optional)
  • Residual Trifluoroacetic acid – <0.25%
  • Residual organic solvents – ICH guidelines or dosage dependent
  • Bioburden – USP or EP guidelines
  • Endotoxin – USP or EP guidelines or dosage dependent
  • Other API – specific parameters- tailored to specific needs

Tests and specifications may change as data is gathered from various manufacturing lots throughout the product life cycle.