Designation:E2810−11´2StandardPracticeforDemonstratingCapabilitytoComplywiththeTestforUniformityofDosageUnits1ThisstandardisissuedunderthefixeddesignationE2810;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.ε1NOTE—EditorialcorrectionsmadethroughoutinFebruary2013.ε2NOTE—EditorialcorrectionsmadethroughoutinDecember2013.1.Scope1.1Thispracticeprovidesageneralprocedureforevaluat-ingthecapabilitytocomplywiththeUniformityofDosageUnits(UDU)test.ThistestisgiveninGeneralChapter<905>UniformityofDosageUnitsoftheUSP,in2.9.40UniformityofDosageUnitsofthePh.Eur.,andin6.02UniformityofDosageUnitsoftheJP,andtheseversionsarevirtuallyinterchangeable.Forthismultiple-stagetest,theprocedurecomputesalowerboundontheprobabilityofpassingtheUDUtest,basedonstatisticalestimatesmadeataprescribedconfidencelevelfromasampleofdosageunits.1.2Thismethodologycanbeusedtogenerateanacceptancelimittable,whichdefinesasetofsamplemeansandstandarddeviationsthatassurespassingtheUDUtestforaprescribedlowerprobabilitybound,confidencelevel,andsamplesize.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E2363TerminologyRelatingtoProcessAnalyticalTechnol-ogyinthePharmaceuticalIndustryE2709PracticeforDemonstratingCapabilitytoComplywithanAcceptanceProcedure2.2OtherDocuments:JPJapanesePharmacopoeia3Ph.Eur.EuropeanPharmacopoeia4USPUnitedStatesPharmacopeia53.Terminology3.1Definitions—SeeTerminologyE2363foramoreexten-sivelistingoftermsinASTMCommitteeE55standards.3.2DefinitionsofTermsSpecifictoThisStandard:3.2.1acceptableparameterregion,n—thesetofvaluesofparameterscharacterizingthed...
