Nakagawa Y, Maeda H, Murai T, Horiuchi Y
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2000(118):156-8.
To establish the fourth lot (Control 0001) of the Endotoxin 10,000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10,000 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 20,000 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the fourth lot of the Endotoxin 10,000 Reference Standard containing 20,000 EU per vial.
为制备国立卫生科学研究所内毒素10,000参考标准品的第四批（对照0001）（日本药典内毒素10,000参考标准品），制备了候选标准品（CS）并进行了评估。通过5个实验室参与的协作研究，以美国药典内毒素参考标准品（批次G-1）为对照测定了CS的效价，并定义为每瓶约含20,000内毒素单位（EU）。根据结果，CS被批准为第四批内毒素10,000参考标准品，每瓶含20,000 EU。
