Quantitative Determination of Bacterial Endotoxin in Posaconazole Active Pharmaceutical Ingredients by Kinetic Chromogenic Assay
Objective:To establish a kinetic chromogenic method for the quantification of bacterial endotoxin in water-insoluble active pharmaceutical ingredients(API)of posaconazole.Methods:Based on the clinical dosage of posaconazole injection,a strict limit of 0.25 EU·mg-1 for the posaconazole API was formulated.The posaconazole API was dissolved with a diluent(dimethyl sulfoxide:RIPA strong lysis solution=1∶1)as a solvent,and kinetic chromogenic limulus amebocyte lysate reagents from two manufacturers were used.According to method 2(photometry)in the general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),the mass concen-tration range of the sample was determined using the kinetic chromogenic assay.Finally,the bacterial endotoxin of three batches of sam-ples was quantitatively detected.Results:The absolute correlation coefficients of the standard curves of limulus amebocyte lysate from two manufacturers were greater than 0.980.When the sample mass concentration was ≤0.02 mg·mL-1,the recoveries of bacterial endotox-in were in the range;The quantitative detection results of bacterial endotoxin in three batches of samples all met the requirements.Conclusion:With a limit of 0.25 EU·mg-1,the kinetic chromogenic assay is feasible and controllable for the quantitative determination of bacterial endotoxin in water insoluble posaconazole API.
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