Limulus amoebocyte lysate assay for detection and quantitation of endotoxin in a small-volume parenteral product | Zendy

K Tsuji | Zendy; Kathy A. Steindler | Zendy; S J Harrison | Zendy

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Limulus amoebocyte lysate assay for detection and quantitation of endotoxin in a small-volume parenteral product

Author(s) -

K Tsuji,

Kathy A. Steindler,

S J Harrison

Publication year - 1980

Publication title -

applied and environmental microbiology

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.552

H-Index - 324

eISSN - 1070-6291

pISSN - 0099-2240

DOI - 10.1128/aem.40.3.533-538.1980

Subject(s) - limulus , monobasic acid , chemistry , chromatography , dilution , potassium phosphate , lysis , potassium , biology , biochemistry , paleontology , physics , organic chemistry , polymer chemistry , thermodynamics

A Limulus amoebocyte lysate gel-clotting method for the determination of endotoxin in a small-volume parenteral product has been described. Sample dilution with 0.1 M potassium phosphate monobasic buffer (pH 8.0) effectively eliminated assay interference, whereas dilution with water did not. The threshold pyrogenic dose for Escherichia coli EC-2 and O127:B8 endotoxins was determined to be 1.0 ng of endotoxin per kg of body weight. Not more than 1.0 ng of endotoxin (the threshold pyrogenic dose) per the highest recommended human dose or the USP pyrogen test dose per kg of body weight, whichever dose is more stringent, is a logical limit for the quantity of bacterial endotoxin in small-volume parenteral products. Excellent correlation was attained when this criterion was used to compare the Limulus amoebocyte lysate assay with the USP pyrogen test.

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