ASTM E281011原文.docx

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1、Designation:E2810-11(Reapproved2017)StandardPracticeforDemonstratingCapabi1itytoComp1ywiththeTestforUniformityofDosageUnitsThispracticeisunderthejurisdictionofASTMCommitteeE55onManufiictureofPharmaceutica1andBiopharmaceutica1Productsandisthedirectresponsibi1ityofSubcommitteeE55.03onGenera1Pharmaceut

2、ica1Standards.CurrenteditionapprovedOct.1,2017.Pub1ishedOctober2017.Origina11yapprovedin2011.1astpreviouseditionapprovedin2011asE2810-112.DOI:10.1520E2810-11R17.ThisstandardisissuedunderthefixeddesignationE2810;thenumberimmediate1yfo11owingthedesignationindicatestheyearoforigina1adoptionor,inthecase

3、ofrevision,theyearof1astrevision.Anumberinparenthesesindicatestheyearof1astreapprova1.Asuperscriptepsi1on(z)indicatesaneditoria1changesincethe1astrevisionorreapprova1.1. Scope1.1 Thispracticeprovidesagenera1procedureforeva1uatingthecapabi1itytocomp1ywiththeUniformityofDosageUnits(UDU)test.Thistestis

4、giveninGenera1ChapterUniformityofDosageUnitsoftheUSP,in2.9.40UniformityofDosageUnitsofthePh.Eur.,andin6.02UniformityofDosageUnitsoftheJP,andtheseversionsarevirtua11yinterchangeab1e.Forthismu1tip1e-stagetest,theprocedurecomputesa1owerboundontheprobabi1ityofpassingtheUDUtest,basedonstatistica1estimate

5、smadeataprescribedconfidence1eve1fromasamp1eofdosageunits.1.2 Thismethodo1ogycanbeusedtogenerateanacceptance1imittab1e,whichdefinesasetofsamp1emeansandstandarddeviationsthatassurespassingtheUDUtestforaprescribed1owerprobabi1itybound,confidence1eve1,andsamp1esize.1.3 Thisstandarddoesnotpurporttoaddre

6、ssa11ofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibi1ityoftheuserofthisstandardtoestab1ishappropriatesafety,hea1th,andenvironmenta1practicesanddeterminetheapp1icabi1ityofregu1atory1imitationspriortouse.1.4 Thisinternationa1standardwasdeve1opedinaccordancewithinternationa11yrecognize

7、dprincip1esonstandardizationestab1ishedintheDecisiononPrincip1esfortheDeve1opmentofInternationa1Standards,GuidesandRecommendationsissuedbytheWor1dTradeOrganizationTechnica1BarrierstoTrade(TBT)Committee.2. ReferencedDocuments2.1 ASTMStandards:ForreferencedASTMstandards,visittheASTMwebsite,www.asim.or

8、g,orcontactASTMCustomerServiceatserviceastm.org.ForAnnua1BookofASTMStandardsvo1umeinformation,refertothestandardsDocumentSummarypageontheASTMwebsite.E2363Termino1ogyRe1atingtoProcessAna1ytica1Techno1ogyinthePharmaceutica1IndustryE2709PracticeforDemonstratingCapabi1itytoComp1ywithanAcceptanceProcedur

9、e2.2 OtherDocuments:JPJapanesePharmacopoeiaAvai1ab1efromthePharmaceutica1sandMedica1DevicesAgency(PMDA),Shin-KasumigasekiBui1ding,3-3-2Kasumigaseki,Chiyoda-ku,Tokyo100-0013,Japan,https:/www.pmda.go.jp.Ph.Eur.EuropeanPharmacopoeiaAvai1ab1efromtheEuropeanDirectoratefortheQua1ityofMedicinesandHea1thCar

10、e(EDQM),Counci1ofEurope,7a11eeKastner,CS30026,F-67081Strasbourg,France,http:/www.edqm.eu.USPUnitedStatesPharmacopeiaAvai1ab1efromU.S.Pharmacopeia!Convention(USP),12601TwinbrookPkwy.,Rockvi11e,MD20852-1790,http:/www.usp.org.3. Termino1ogy3.1 Definitions-SeeTermino1ogyE2363foramoreextensive1istingofte

11、rmsinASTMCommitteeE55standards.3.2 DefinitionsofTermsSpecifictoThisStandard:3.2.1 acceptab1eparameterregion,n一thesetofva1uesofparameterscharacterizingthedistributionoftestresu1tsforwhichtheprobabi1ityofpassingthe1otacceptanceprocedureisgreaterthanaprescribed1owerbound.3.2.2 Acceptance1imit,nthebound

12、aryoftheacceptanceregion,forexamp1e,themaximumsamp1estandarddeviationforagivensamp1emean.3.2.2.1Discussionthecoefficientofvariation(re1ativestandarddeviation)maybesubstitutedforthestandarddeviationwhereapp1icab1e.3.2.3acceptanceregion,n一thesetofva1uesofparameterestimates(thatis,samp1emeanandstandard

13、deviation)whereconfidence1imitsattainaprescribed1owerboundontheprobabi1ityofpassinga1otacceptanceprocedure.3.2.4Confidence1eve1,C,n一theprescribedovera111eve1forca1cu1atingtheuncertaintyregionoftheparametersfromthesamp1eestimates.1.1.1.1 Discussion-Thepresetconfidence1eve1isstatedasapercentage,forexa

14、mp1e,100(1-)=95%,whereaisariskthatisa11ocatedtothetwoparametersbeingestimated.3.2.5 1owerprobabi1itybound,1B,nthenomina1probabi1ityofpassingtheUDUtestforagivensetofparameterestimates.3.2.6 mu1tip1e-stageacceptanceprocedure,n一aprocedurethatinvo1vesmorethanonestageofsamp1ingandtestingagivenqua1itychar

15、acteristicwithoneormoreacceptancecriteriaperstage.3.2.7 representativesamp1e,n一asamp1ethatconsistsofanumberofunitsthataredrawnbasedonrationa1criteriasuchasrandomsamp1ingandintendedtoassurethatthesamp1eaccurate1yportraysthemateria1beingsamp1ed3.2.8 samp1ingp1an,nschemeforse1ectingdosageunitsfrom1ocat

16、ionswithinabatchfortestingpurposes.3.2.8.1 Discussion-Inthisstandard,asing1edosageunitisse1ectedfromeachbatch1ocation.3.2.9 uniformityofdosageunits,UDU,nthedegreeofuniformityintheamountofthedrugsubstanceamongdosageunits.3.2.9.1 Discussion-TherequirementsoftheUDUtestapp1ytoeachdrugsubstanceindosageunitscontainingoneormoredrugsubstances,un1essotherwisespecified.Theuniformityimprovesasthevariabi1itydecreases.