[The Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 Reference Standard) (Control 0211)].
To establish the fifth lot (Control 0211) of the Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 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 a s containing approximately 16,000 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 fifth lot of the Endotoxin 10000 Reference Standard containing 16,000 EU per vial.
Nakagawa
Yukari
Y
yukari@nihs.go.jp
Murai
Toshimi
T
Horiuchi
Yoshinobu
Y
D004731:Endotoxins / Q000032:analysis / Q000592:standards*; D006077:Government Agencies; D007564:Japan; D010602:Pharmacopoeias as Topic / Q000592:standards; D012015:Reference Standards
D004731:Endotoxins