Appearance – White to Off white powder
Solubility – clear solution of a pre-specified concentration
Identity – correct molecular weight, correct sequence and composition by MS/MS sequencing
Amino acid composition and Chiral purity
Peptide purity (UHPLC) – 95-99% tailored to product stage and requirements
Counterion content – product dependent (typically acetate)
Moisture content – <1-5%
Mass balance – 95-120% (compound dependent – typically 110-120%)
Residual Trifluoroacetic acid – <0.1%
Other API – specific parameters- tailored to specific needs