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1、Accessedfrom10.6.1.1bykpot4rtgfonSunOct1621:00:57EDT2016USP39GeneralRequirements/á1ñInjections69tionasconstitutedforadministrationarenotincludedintheindividualmonographsonsteriledrysolidsorliquidconcentrates.However,intheinterestofassuringthequalityofinjectionpreparations
2、astheyareactuallyadministered,thefollowingnon-destructivetestsareprovidedfordemonstratingthesuitabilityofconstitutedsolutionswhentheyarepreparedjustpriortouse.CompletenessandClarityofSolution—Constitutethesolutionasdirectedinthelabelingsuppliedbythemanufacturerforthesteri
3、ledrydosageform.A:Thesoliddissolvescompletely,leavingnovisibleresidueasundissolvedmatter.B:TheconstitutedsolutionisnotsignificantlylessclearthananequalvolumeofthediluentorofPurifiedWatercontainedinasimilarvesselandexaminedsimilarly.ParticulateMatter—Constitutethesolutiona
4、sdirectedinthelabelingsuppliedbythemanufacturerforthesteriledrydos-ageform:thesolutionisessentiallyfreefromparticlesofforeignmatterthatcanbeobservedonvisualinspection.á1ñINJECTIONSANDIMPLANTEDDRUGPRODUCTS(PARENTERALS)—PRODUCTQUALITYTESTS(ChaptertobecomeofficialMay1,2016)G
5、eneralChapters(Currentchapternameisá1ñInjections)INTRODUCTIONParenteraldrugproductsincludebothinjectionsandimplanteddrugproductsthatareinjectedthroughtheskinorotherexternalboundarytissue,orimplantedwithinthebodytoallowthedirectadministrationoftheactivedrugsubstance(s)into
6、bloodvessels,organs,tissues,orlesions.Injectionsmayexistaseitherimmediate-orextended-releasedosageforms.Implan-tedparenteraldrugproductsarelong-actingdosageformsthatprovidecontinuousreleaseoftheactivedrugsubstance(s)of-tenforperiodsofmonthstoyears.Forsystemicdelivery,they
7、maybeplacedsubcutaneously;forlocaldelivery,theymaybeplacedinaspecificregionofthebody.Routesofadministrationforparenteraldrugproductsincludeintravenous,intraventric-ular,intra-arterial,intra-articular,subcutaneous,intramuscular,intrathecal,intracisternal,andintraocular.Par
8、enteraldosageformsincludesolutions,suspensions,emulsions,sterilepowdersforsolutionsandsuspension
