usp〈85〉 细菌内毒素检查 BACTERIAL ENDOTOXINS TEST中文版.docx

Printedon:MonAug092021,06:41:34PM(EST)

Printedby:NguyenNhan

OfficialStatus:CurrentlyOfficialon09-Aug-2021

OfficialDate:Officialasof01-May-2018

DocId:1_GUID-F9D9BFA5-099F-452C-9711-47674B37C1CC2en-US

DocumentType:GENERALCHAPTER@2021USPC

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85BACTERIALENDOTOXINSTEST细菌内毒素检查

◆PortionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopoeia

and/ortheJapanesePharmacopoeia.Thoseportionsthatarenotharmonizedaremarkedwithsymbols(◆◆)tospecifythisfact.◆

TheBacterialEndotoxinsTest(BET)isatesttodetectorquantifyendotoxinsfromGram-negativebacteriausingamoebocytelysatefromthehorseshoecrab(LimuluspolyphemusorTachypleustridentatus).

Therearethreetechniquesforthistest:thegel-clottechnique,whichisbasedongelformation;theturbidimetrictechnique,basedonthedevelopmentofturbidityaftercleavageofanendogenoussubstrate;andthechromogenictechnique,basedonthedevelopmentofcoloraftercleavageofasyntheticpeptide-chromogencomplex.Proceedbyanyofthethreetechniquesforthetest.Intheeventofdoubtordispute,thefinaldecisionismadebaseduponthegel-clotlimittestunlessotherwise

indicatedinthemonographfortheproductbeingtested.Thetestiscarriedoutinamannerthatavoidsendotoxincontamination.

本总章的部分内容已与《欧洲药典》和/或《日本药典》的相应文本相一致。不协调

本总章的部分内容已与《欧洲药典》和/或《日本药典》的相应文本相一致。不协调的部分用符号标记(◆◆)以说明这一事实。细菌内毒素测试（BET）是一种使用鲎（鲎或三齿鲎）阿米巴细胞裂解物检测或量化革兰氏阴性细菌内毒素的测试。

该测试有三种技术：基于凝胶形成的凝胶凝块技术；浊度测定技术，基于内源性底物裂解后浊度的发展；以及基于合成肽显色复合物裂解后颜色的发展的显色技术。按照三种测试方法中的任何一种进行测试。如有疑问或争议，最终决定将根据凝胶凝块限度测试做出,除非所测试产品的专论中另有说明。以避免内毒素污染的方式进行测试。

APPARATUS仪器

Depyrogenateallglasswareandotherheat-stablematerialsinahotairovenusingavalidatedprocess.◆1◆Acommonlyusedminimumtimeandtemperatureis30minat250°.Ifemployingplasticapparatus,suchasmicroplatesandpipet