TABLE I

Kinetic Parameters for RSE Activity Change in LER Solutions Containing Citrate

Citrate (mM)Polysorbate 20 (%)pHTemperature (°C)NaCl (%)RSE (EU/mL)kY-interceptr
0.50.057.4230.85.00.98−0.040.977
10.057.4230.85.01.4−0.090.970
20.057.4230.85.02.3−0.240.987
50.057.4230.85.02.9−0.060.995
100.057.4200.20.048−0.010.644
100.057.4202.00.037−0.070.657
100.057.42305.04.6−0.170.998
100.057.4230.85.03.2−0.150.998
100.27.4230.85.03.4−0.130.998
100.00017.4230.85.00.077−0.290.195
100.0017.4230.85.01.4−0.170.981
100.017.4230.85.03.2−0.090.995
100.057.4232.05.01.8−0.070.984
100.057.4233.05.00.71−0.200.914
100.056.42305.00.61−0.310.930
100.056.92305.00.93−0.090.989
100.057.42300.22.5−0.150.990
100.057.42300.23.5−0.130.989
100.057.82305.07.6−0.040.996
100.057.43002.09.3−0.330.991
100.057.33005.013−0.310.993
100.057.43602.032−0.540.986
100.057.33605.042−0.110.999
250.057.4230.75.02.9−0.050.993
  • *Plotting incubation time versus the natural logarithm of reciprocals of endotoxin recovery provided the kinetic parameters, reaction rate constant k, y-intercept, and correlation coefficients r.