Validation of the Chromogenic Bioassay for the Potency Assessment of Streptokinase in Biopharmaceutical Formulations

Abstract

JABT, an open access journal and quantitation limits, were multiplied by the ratio of the standard deviation of the intercept and the slope, respectively. The QL was also evaluated in an experimental assay. Robustness:The robustness of an analytical procedure refers to its ability to remain unaffected by small and deliberate variations in method parameters and provides an indication of its reliability for the routine analysis. The robustness of the SCSA was determined by analyzing the same samples containing 1 500 000 IU/mL and 750 000 IU/mL, respectively, under a variety of conditions of the assay parameters, such as: reaction time with plasminogen (5, 10 and 15 minutes), reaction time with substrate chromogenic (1, 2 and 3 minutes), pH of buffer solution (pH 7.4, 7.7 and pH 8.0), assay temperature (34, 37, 40°C) and stability of the analytical solution at 2-8°C.