USP39-注射剂通则

tionasconstitutedforadministrationarenotincludedintheindividualmonographsonsteriledrysolidsorliquidconcentrates.However,intheinterestofassuringthequalityofinjectionpreparationsastheyareactuallyadministered,thefollowingnon-destructivetestsareprovidedfordemonstratingthesuitabilityofconstitutedsolutionswhentheyarepreparedjustpriortouse.CompletenessandClarityofSolution—Constitutethesolutionasdirectedinthelabelingsuppliedbythemanufacturerforthesteriledrydosageform.A:Thesoliddissolvescompletely,leavingnovisibleresidueasundissolvedmatter.B:TheconstitutedsolutionisnotsignificantlylessclearthananequalvolumeofthediluentorofPurifiedWatercontainedinasimilarvesselandexaminedsimilarly.ParticulateMatter—Constitutethesolutionasdirectedinthelabelingsuppliedbythemanufacturerforthesteriledrydos-ageform:thesolutionisessentiallyfreefromparticlesofforeignmatterthatcanbeobservedonvisualinspection.á1ñINJECTIONSANDIMPLANTEDDRUGPRODUCTS(PARENTERALS)—PRODUCTQUALITYTESTS(ChaptertobecomeofficialMay1,2016)(Currentchapternameisá1ñInjections)INTRODUCTIONParenteraldrugproductsincludebothinjectionsandimplanteddrugproductsthatareinjectedthroughtheskinorotherexternalboundarytissue,orimplantedwithinthebodytoallowthedirectadministrationoftheactivedrugsubstance(s)intobloodvessels,organs,tissues,orlesions.Injectionsmayexistaseitherimmediate-orextended-releasedosageforms.Implan-tedparenteraldrugproductsarelong-actingdosageformsthatprovidecontinuousreleaseoftheactivedrugsubstance(s)of-tenforperiodsofmonthstoyears.Forsystemicdelivery,theymaybeplacedsubcutaneously;forlocaldelivery,theymaybeplacedinaspecificregionofthebody.Routesofadministrationforparenteraldrugproductsincludeintravenous,intraventric-ular,intra-arterial,intra-articular,subcutaneous,intramuscular,intrathecal,intracisternal,andintraocular.Parenteraldosageformsincludesolutions,suspensions,emulsions,sterilepowdersforsolutionsandsuspensions(includingliposomes),implants(includingmicroparticles),andproductsthatconsistofbothadrugandadevicesuchasdrug-elutingstents.ThereaderisdirectedtoPharmaceuticalDosageFormsá1151ñ1andtothelatersectionsofthischapterforadditionaldescriptionsofdosageformsthatfallintothegeneralcategoryofparenteraldrugproducts.Nomenclatureá1121ñ1providesinformationonnomenclatureusedtoestablishUSPnamesandmonographtitlesforparenteraldrugproducts.Chapterá1ñprovidesaframeworktosupporttherevisionandthedevelopmentofindividualmonographs,andisnotmeanttoreplaceindividualmonographs.Chapterá1ñprovideslistsofcommonproductqualitytestrequirementsinaconciseandacoherentfashion.Thechapterisdividedintofourmainsections:(1)universalproductqualityteststhatareapplicabletopa-rentaldosageforms;(2)specificproductqualitytests,whichareteststhatshouldbeconsideredinadditiontoUniversalTests;(3)productqualitytestsforspecificdosageforms,whichlistsalltheapplicabletests(UniversalandSpecific)forthespecificdosageform;and(4)productperformancetests.Ifamonographexists,itwillreferenceá1ñorindicatedchapterparts.Ifaspecificdrugproductmonographismissing(notinexistence),thegeneralchaptersprovidethequalityteststhatcanbeusedbymanufacturersuntilthedosageformmonographisdevelopedbyUSP.ThePharmacopeialdefinitionsforsterilepreparationsforparenteralusemaynotapplytosomebiologicsbecauseoftheirspecialnatureandlicensingrequirements(seeBiologicsá1041ñ1).However,somebiologicalfinisheddrugproductscontaining“Injection”inthemonographtitlemustmeettherequirementsofá1ñorindicatedchaptersubparts,whereitisspecifiedinthemonograph.DrugProductQualityandDrugProductPerformanceTestsProceduresandacceptancecriteriafortestingparenteraldrugproductsaredividedintotwocategories:(1)thosethatassessproductqualityattributes,e.g.,identification,sterility,andparticulatematter,andarecontainedinthischapterand(2)thosethatassessproductperformance,e.g.,invitroreleaseofthedrugsubstancefromthedrugproduct.Whereasqualitytestsas-sesstheintegrityofthedosageform,theperformancetestsassessperformance(bioavailability)aftertheproducthasbeenadministeredtothepatient.Aproductperformancetest,i.e.,drugreleasetestforsuspensions,emulsions,powderforsuspen-sion(includingmicroparticlesandliposomes),anddrug-elutingstents,shouldbecarriedoutusingappropriatetestproce-dures.1Alllistedchaptersaboveá1000ñareforinformationpurposesonly;theymaybehelpfulbutarenotmandatory.GeneralChaptersUSP39GeneralRequirements/á1ñInjections69OfficialfromDecember1,2016Copyright(c)2016TheUnitedStatesPharmacopeialConvention.Allrightsreserved.Accessedfrom10.6.1.1bykpot4rtgfonSunOct1621:00:57EDT2016Changetoread:PRODUCTQUALITYTESTSCOMMONTOPARENTERALDOSAGEFORMSUniversalTestsUniversaltestsarelistedbelowandareapplicabletoparenteraldosageforms.Description:Aqualitativedescriptionofthedosageformshouldbeprovided.Theacceptancecriteriashouldincludethefi-nalacceptableappearance.Ifcolorchangesduringstorage,aquantitativeorasemiquantitativeproceduremaybeappropri-ate.Thissectionspecifiesthecontentorthelabelclaimofthearticle(seeLabelingá7ñ).Additionalinformationaboutcommon-lyusedtermsanddefinitionscanbefoundinNomenclatureá1121ñ1.Identi