USP 711 溶出度2012年2月最新美国药典溶出度检查

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1、RevisionBulletinOfficialFebruary1,2012á711ñDissolution1material1;amotor;ametallicdriveshaft;andacylindricalá711ñDISSOLUTIONbasket.Thevesselispartiallyimmersedinasuitablewaterbathofanyconvenientsizeorheatedbyasuitabledevicesuchasaheatingjacket.Thewaterbathorheatingdevice

2、permitsholdingthetemperatureinsidethevesselatThisgeneralchapterisharmonizedwiththecorrespond-37±0.5°duringthetestandkeepingthebathfluidincon-ingtextsoftheEuropeanPharmacopoeiaand/ortheJapa-stant,smoothmotion.Nopartoftheassembly,includingnesePharmacopoeia.Thesepharmacope

3、iashaveundertakentheenvironmentinwhichtheassemblyisplaced,contrib-nottomakeanyunilateralchangetothisharmonizedutessignificantmotion,agitation,orvibrationbeyondthatchapter.duetothesmoothlyrotatingstirringelement.AnapparatusPortionsofthepresentgeneralchaptertextthatarena-

4、thatpermitsobservationofthespecimenandstirringele-tionalUSPtext,andthereforenotpartoftheharmonizedtext,aremarkedwithsymbols(✦mentduringthetestispreferable.Thevesseliscylindrical,✦)tospecifythisfact.withahemisphericalbottomand✦withoneofthefollow-Thistestisprovidedtodeter

5、minecompliancewiththedissolutionrequirements✦wherestatedintheindividualingdimensionsandcapacities:foranominal✦capacityof1L,theheightis160to210mmanditsinsidediameterismonograph✦fordosageformsadministeredorally.Inthis98to106mm;✦foranominalcapacityof2L,theheightisgeneralch

6、apter,adosageunitisdefinedas1tabletor1capsuleortheamountspecified.✦Ofthetypesofapparatus280to300mmanditsinsidediameteris98to106mm;andforanominalcapacityof4L,theheightis280to300describedherein,usetheonespecifiedintheindividualmmanditsinsidediameteris145to155mm✦.Itssidesm

7、onograph.Wherethelabelstatesthatanarticleisen-areflangedatthetop.Afittedcovermaybeusedtoretardteric-coated,andwhereadissolutionordisintegrationtestevaporation.2Theshaftispositionedsothatitsaxisisnotthatdoesnotspecificallystatethatitistobeappliedtomorethan2mmatanypointfr

8、omtheverticalaxisofthedelayed-releasearticlesisincludedintheindividualmono-vesselandrotatessmoothlyandwithouts