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1、<788>PARTICULATEMATTERININJECTIONSParticulatematterininjectionsandparenteralinfusionsconsistsofmobileundissolvedparticles,otherthangasbubbles,unintentionallypresentinthesolutions.Forthedeterminationofparticulatematter,twoprocedures,Method1(LightObscurationParticleC
2、ountTest)andMethod2(MicroscopicParticleCountTest),arespecifiedhereinafter.Whenexamininginjectionsandparenteralinfusionsforsub-visibleparticlesMethod1ispreferablyapplied.However,itmaybenecessarytotestsomepreparationsbythelightobscurationparticlecounttestfollowedbyth
3、emicroscopicparticlecounttesttoreachaconclusiononconformancetotherequirements.Notallparenteralpreparationscanbeexaminedforsub-visibleparticlesbyoneorbothofthesemethods.WhenMethod1isnotapplicable,e.g.incaseofpreparationshavingreducedclarityorincreasedviscosity,thete
4、stshouldbecarriedoutaccordingtoMethod2.Emulsions,colloids,andliposomalpreparationsareexamples.Similarly,productsthatproduceairorgasbubbleswhendrawnintothesensormayalsorequiremicroscopicparticlecounttesting.Iftheviscosityofthepreparationtobetestedissufficientlyhighs
5、oastoprecludeitsexaminationbyeithertestmethod,aquantitativedilutionwithanappropriatediluentmaybemadetodecreaseviscosity,asnecessary,toallowtheanalysistobeperformed.Theresultsobtainedinexaminingadiscreteunitorgroupofunitsforparticulatemattercannotbeextrapolatedwithc
6、ertaintytootherunitsthatremainuntested.Thus,statisticallysoundsamplingplansmustbedevelopedifvalidinferencesaretobedrawnfromobserveddatatocharacterizethelevelofparticulatematterinalargegroupofunits.METHOD1.LIGHTOBSCURATIONPARTICLECOUNTTESTUseasuitableapparatusbasedo
7、ntheprincipleoflightblockagewhichallowsanautomaticdeterminationofthesizeofparticlesandthenumberofparticlesaccordingtosize.Thedefinitionforparticle-freewaterisprovidedinReagentSpecificationsunderReagents,IndicatorsandSolutionsection.Theapparatusiscalibratedusingdisp
8、ersionsofsphericalparticlesofknownsizesbetween10µmand25µm,USPParticleCountReferenceStandard.Thesestandardparticlesaredispersedinparticle-freewate
