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 sa...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.展开更多
文摘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.
