Application of the Limulus Test for Practical Quality Control on Endotoxin Content in Commercial Human Serum Albumin (HSA) Products. In Comparison with the Rabbit Pyrogen Test

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  • ヒト血清アルブミン製剤中のエンドトキシン量の測定に対するリムルス試験の応用.ウサギ発熱試験との比較
  • ヒト ケッセイ アルブミン セイザイチュウ ノ エンドトキシンリョウ ノ ソク

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Abstract

The bacterial endotoxin content in human serum albumin (HSA) products measured by two different Limulus amebocyte lysate (LAL) test methods, colorimetric and kinetic turbidimetric methods, were compared. So far as endotoxin-specific LAL reagents which do not show a false-positive reaction with (1→3)-β-D-glucan are used, a definite correlation was found between the results with the two LAL test methods. Endotoxin added to HSA products was recovered in a quantitative manner showing neither inhibition nor enhancement by HSA to the both LAL test methods. Results of the LAL tests showed a significant correlation with that of the rabbit pyrogen test. The correlation was much improved with endotoxin-added HSA. The present results indicate the practical applicability of the LAL test as an alternative method for the rabbit pyrogen test.

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 114 (11), 888-893, 1994

    The Pharmaceutical Society of Japan

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