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Home » About Us » Quality

Analytical development and validation are part of the GMP process to support and justify the specifications for releasing the API. We make a point of performing analytical development early in any project to ensure that no undetected impurities emerge during analytical
validation.

• Our standard GMP specifications include
  
• Appearance
• Solubility
• Identity (via mass spectral analysis, amino acid analysis and HPLC)
• Peptide purity (HPLC)
• Related substances (HPLC)
• Assay (peptide content)
• Counterion content
• Moisture content
• Mass balance
• Trifluoroacetic acid
• Residual organic solvents
• Bioburden
• Endotoxin
• Other API-specific parameters