Application of kinetic turbidimetric limulus test to Sodium Ferulate for injection / 中成药

ABSTRACT

Objective: The kinetic turbidimetric limulus test was used in the endotoxin assay of Sodium Ferulate for injection. Methods: The preliminary validation test was fulfilled, when the standard endotoxin spiked in Sodium Ferulate for injection sample (Lot. No. 20000704) and its 10 fold dilution、 20 fold dilution、 40 fold dilution、 60 dilution、 80 fold dilution. The recoveries were 0.20%, 74.70%, 87.93%, 87.09%, 98.55%, 119.2% respectively. The optimum detection concentration found was 60 fold dilution. During the formal interference tests of 3 batches of Sodium Ferulate for injection (Lot. No. 20000308 20000704 20000315), the recoveries were 120.4%,98.55% and 85.40% respectively. Results: 5.00,0.500,0.0500 Eu/mL of standard endotoxin were used. The standard endotoxin was quantitatively added into the 60 fold dilution of Sodium Ferulate for injection. The recoveries were all 50%～200% and no interference action was found.Conclusion: The kinetict turbidimetric limulus test provided a new way to the detection of endotoxin in Sodium Ferulate for injection.