Volume of peptide DS solution (unformulated) Volume of PS20/PS80 stock solution (1 mg/ml) Volume of neat m-cresol (density=1.03 mg/µl) Volume of water PS20/PS80 concentration in peptide formulations m-Cresol concentration in peptide formulations 10 ml 0.2 ml 54.4 µl 9.8 ml 10 ppm 2.8 mg/ml 10 ml 0.3 ml 54.4 µl 9.7 ml 15 ppm 2.8 mg/ml 10 ml 0.4 ml 54.4 µl 9.6 ml 20 ppm 2.8 mg/ml 10 ml 1.0 ml 54.4 µl 9.0 ml 50 ppm 2.8 mg/ml

Table 2: Dilution scheme for the evaluation of m-cresol and polysorbate compatibility in peptide formulations.