Bacterial Endotoxin Testing

BacterialEndotoxinTesting

Bacterialendotoxinisacomplexoflipopolysaccharide(LPS)andproteininthecell wallofgram-negativebacteria,whichisreleasedwhenthebacteriadieorautolysis.A largeamountofendotoxinentersthebloodstreamandcausesafebrilereaction-a "pyrogenicreaction".Ifendotoxinentersandcollectsinthebloodinlargequantities andexceedstheclearancecapacityofthebody'sself-defensesystem,endotoxemiaof differentdegreesmayresultTherefore,biologicalproducts,pharmaceuticalsfor injection,chemicals,radiopharmaceuticals,antibiotics,vaccines,dialysissolutions andotherpreparations,aswellasmedicaldevices(suchasdisposablesyringesand implantablebiologicalmaterials)mustbetestedforbacterialendotoxinbeforeuse

Differentsamplesneedtofindthecorrespondinginterferingfactors,findthetypeof interferingeffect,findthemethodtoeliminatetheinterference,gothroughmethod validation,determinethemethod,andthenperformdailytesting

FrequentlyAskedQuestions

Howtopretreattheinsolublewaterdonor?

Fig.13Dimageofbacterialendotoxin

Thecorrespondingsolventcanbeselectedaccordingtothecharacteristicsofthetest itself,suchasdimethylsulfoxide,ethanol,etc.Correspondingsolvents,needtobe verifiedwithoutinterferenceeffectanditsownendotoxincontent.

Howmanytimesdoesthemethodapplicabilitystudyneedtobeconducted?

Whenestablishingendotoxinscreeningmethodsforinjectabledrugsandbiological products,itisnecessarytousetwomultiplereagentmanufacturersatthesametime, andatleastthreebatchesofsamplesofeachspeciesforinterferencetesting.

Source:https://wwwformulationbiocom/bacterial-endotoxin-testinghtml