肝素钠 USP40.pdf

Accessed from by brunswick20 on Tue Feb 21 02:42:58 EST 2017 USP 40 Official Monographs / Heparin 4475 Antithrombin IU/mL. Dilute this solution with pH 8.4 Parallel-line assay: For each series, calculate the regres- buffer to obtain a solution having a concentration of sion of the absorbance or change in absorbance/min 0.125 Antithrombin IU/mL. against log concentrations of the Standard solutions and Thrombin human solution: Reconstitute thrombin the Sample solutions, and calculate the potency of Anti- human (factor IIa) (see Reagents, Indicators, and Solu- coagulant Heparin Solution in USP Units/mL using sta- tions—Reagent Specifications) in water to give 20 tistical methods for parallel-line assays. Thrombin IU/mL, and dilute with pH 8.4 buffer to ob- Slope ratio assay: For each series, calculate the regres- tain a solution having a concentration of 5 Thrombin sion of the log absorbance or the log change in absorb- IU/mL. [NOTE—The thrombin should have a specific ac- ance/min against concentrations of the Standard solu- tivity of NLT 750 IU/mg.] tions and the Sample solutions, and calculate the Chromogenic substrate solution: Prepare a solution of potency of Anticoagulant Heparin Solution in USP a suitable chromogenic thrombin substrate for Units/mL using statistical methods for slope ratio assays. amidolytic test (see Reagents, Indicators, and Solutions— Acceptance criteri