title: [The application of the endotoxin test for globulin and other blood products].
abstract: The application of the endotoxin test for globulin and other blood products were investigated by two different limulus amebocyte lysate (LAL) test methods, colorimetric and kinetic turbidimetric methods, using two endotoxin-specific reagents. By the dilution of the blood products in 40 times or more, spiked endotoxin in the products was recovered accurately showing neither inhibition nor enhancement. The definite difference was not shown between the results obtained by the two LAL test methods. According to the method of the endotoxin test described under General Tests of The Japanese Pharmacopeia (thirteenth edition), JPXIII, the maximum valid dilution (MVD) for these products will be calculated to be 40 or more, so it is capable to measure the endotoxin limit for each product. This study indicates that the endotoxin test is applicable to measure the endotoxin content in globulin and other blood products as an alternative method for the rabbit pyrogen test.
authors.affiliation: National Institute of Infectious Diseases, Tokyo, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Fujiwara
authors.forename: K
authors.initials: K
authors.lastname: Kira
authors.forename: S
authors.initials: S
authors.lastname: Asakawa
authors.forename: S
authors.initials: S
authors.lastname: Naito
authors.forename: S
authors.initials: S
authors.lastname: Tanaka
authors.forename: M
authors.initials: M
authors.lastname: Aizawa
authors.forename: M
authors.initials: M
authors.lastname: Tuchiya
authors.forename: A
authors.initials: A
authors.lastname: Takaoka
authors.forename: A
authors.initials: A
authors.lastname: Yamamoto
authors.forename: M
authors.initials: M
authors.lastname: Ochiai
authors.forename: Y
authors.initials: Y
authors.lastname: Horiuchi
mesh_terms: D003124:Colorimetry; D004340:Drug Contamination; D004731:Endotoxins / Q000032:analysis*; D005916:Globulins / Q000737:chemistry*; D006401:Hematologic Agents / Q000737:chemistry*; D008033:Limulus Test / Q000379:methods*; D009391:Nephelometry and Turbidimetry
chemical_list: D004731:Endotoxins; D005916:Globulins; D006401:Hematologic Agents