Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving viable micro-organism
Reexamination Certificate
2006-05-30
2010-11-16
Gitomer, Ralph (Department: 1657)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving viable micro-organism
C435S024000
Reexamination Certificate
active
07833747
ABSTRACT:
An object of the present invention is to provide a method capable of detecting and quantifying endotoxin in a sample in which endotoxin derived from gram-negative bacteria cannot be accurately detected or quantified by the method described in Commentary of the Japanese Pharmacopoeia Fourteenth Edition, Hirokawa Publishing Co. 2001 B-63. It has been found that the above object can be achieved by performing an endotoxin test using a lysate reagent in which the lysate reagent is added into a sample in the presence of albumin and/or globulin.
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Asakawa, Sadao et al., “Application of the Limulus Test for Practical Quality Control on Endotoxin Content in Commercial Human Serum Albumin (HSA) Products. In Comparsion With the Rabbit Pyrogen Test”, vol. 114, No. 11, pp. 888 to 893, 1994.
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Japanese Phamacopoeia Fourteenth Edition, Hirokawa Publishing Co. 2001 B-63 (English Translation) pp. 20-23 w
otes.
Daiichi Sankyo Company, Limited
Gitomer Ralph
Oblon. Spivak. McClelland. Maier & Neustadt. L.L.P.
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