定量法(动态比浊法)测定注射用头孢曲松钠中细菌内毒素的研究

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AIM The kinetic turbidimetric limulus test was used in the endotoxin assay of Ceftriaxone for injection. METHODS The validation test was fulfilled, when the amount of endotoxin spiked in Ceftriaxone for injection sample (Lot. No. 001103) whose concentration of its diluted solution was 10 mg per ml, 5, 2, 1, 0.5 mg/ml. They were recovered in 24.71%,58.71%,88.70%,97.57%,96.79%; with the amount of endotoxin spiked in Ceftriaxone sample (Lot. No. 001103,001106,010106), their 1 mg/ml dilution was recovered in 77 06%,76.17% and 66.71%. RESULTS The standard endotoxin working curve is 5.00,0.500,0.0500 Eu/ml. The 1 mg/ml solution to Ceftriaxone is effective to eliminate the interference in Limulus test. CONCLUSION The kinetic turbidimetric Limulus test provides a new way to the detection of endotoxin in Ceftriaxone for injection. AIM The kinetic turbidimetric limulus test was used in the endotoxin assay of Ceftriaxone for injection. METHODS The validation test was fulfilled, when the amount of endotoxin spiked in Ceftriaxone for injection sample (Lot. No. 001103) whose concentration of its They were recovered in 24.71%, 58.71%, 88.70%, 97.57%, 96.79%; with the amount of endotoxin spiked in Ceftriaxone sample (Lot. No. 001103 , 001106 , 010106), their 1 mg / ml dilution was recovered in 77 06%, 76.17% and 66.71%. RESULTS The standard endotoxin working curve was 5.00, 0.500, 0.0500 Eu / ml. The 1 mg / ml solution to Ceftriaxone is effective to eliminate the interference in Limulus test. CONCLUSION The kinetic turbidimetric Limulus test provides a new way to the detection of endotoxin in Ceftriaxone for injection.
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