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.
