congtainersGlassusp660.docx
- 文档编号:30129869
- 上传时间:2023-08-05
- 格式:DOCX
- 页数:13
- 大小:128.40KB
congtainersGlassusp660.docx
《congtainersGlassusp660.docx》由会员分享,可在线阅读,更多相关《congtainersGlassusp660.docx(13页珍藏版)》请在冰豆网上搜索。
congtainersGlassusp660
660
CONTAINERS—GLASS
Glasscontainersforpharmaceuticaluseareintendedtocomeintodirectcontactwithpharmaceuticalpreparations.Glassusedforpharmaceuticalcontainersiseitheraborosilicate(neutral)glassorasoda-limeglass.Borosilicateglasscontainsasignificantamountofboricoxide,aluminumoxide,andalkaliand/oralkalineearthoxides.Borosilicateglasshasahighhydrolyticresistanceduetothechemicalcompositionoftheglassitself;itisclassifiedasTypeIglass.Soda-limeglassisasilicaglasscontainingalkalimetaloxides.Soda-limeglasshasamoderatehydrolyticresistanceduetothechemicalcompositionoftheglassitself;itisclassifiedasTypeIIIglass.Theinnersurfaceofglasscontainersmaybetreated,forexample,toimprovehydrolyticresistance.ThetreatmentofTypeIIIsoda-limeglasscontainerswillraisetheirhydrolyticresistancefromamoderatetoahighlevel,changingtheclassificationoftheglasstoTypeII.
Theoutersurfaceofglasscontainersmaybetreatedtoreducefrictionorforprotectionagainstabrasionorbreakage.Thetreatmentoftheoutersurfacedoesnotcomeintocontactwiththeinnersurfaceofthecontainer.Glassmaybecoloredtoprovideprotectionfromlightormayhaveacoatingappliedtotheoutersurface.SuchcontainerswillmeettherequirementsforLightTransmissionunderContainers—Permeation
671
.Aclearandcolorlessoratranslucentcontainerthatismadelight-resistantbymeansofanopaqueenclosure(seeLight-ResistantContainerinPreservation,Packaging,Storage,andLabelingundertheGeneralNotices)isexemptfromtherequirementsforLightTransmission.
Thequalityofglasscontainersisdefinedbymeasuringtheirresistancetochemicalattack.Inaddition,TypeIcontainersforaqueousparenteralpreparationsaretestedforarsenicrelease,andcoloredglasscontainersaretestedforlighttransmission.
CHEMICALRESISTANCE
Thefollowingtestsaredesignedtodeterminetheresistancetowaterattackofnew(notpreviouslyused)glasscontainers.Thedegreeofattackisdeterminedbytheamountofalkalireleasedfromtheglassundertheinfluenceoftheattackingmediumundertheconditionsspecified.Thisquantityofalkaliisextremelysmallinthecaseofthemoreresistantglasses,thuscallingforparticularattentiontoalldetailsofthetestsandtheuseofapparatusofhighqualityandprecision.Thetestsshouldbeconductedinanarearelativelyfreefromfumesandexcessivedust.
GlassTypes—GlasscontainerssuitableforpackagingPharmacopeialpreparationsmaybeclassifiedasinTable1onthebasisofthetestssetforthinthissection.ContainersofTypeIborosilicateglassaregenerallyusedforpreparationsthatareintendedforparenteraladministration.ContainersofTypeIglass,orofTypeIIglass(i.e.,soda-limeglassthatissuitablydealkalized)areusuallyusedforpackagingacidicandneutralparenteralpreparations.TypeIglasscontainers,orTypeIIglasscontainers(wherestabilitydatademonstratetheirsuitability),areusedforalkalineparenteralpreparations.TypeIIIsoda-limeglasscontainersusuallyarenotusedforparenteralpreparations,exceptwheresuitablestabilitytestdataindicatethatTypeIIIglassissatisfactoryfortheparenteralpreparationsthatarepackagedtherein.
Table1.GlassTypes
Type
GeneralDescription
TypeofTest
I
Highlyresistant,borosilicateglass
PowderedGlass
II
Treatedsoda-limeglass
WaterAttack
III
Soda-limeglass
PowderedGlass
Apparatus—
Autoclave—Forthesetests,useanautoclavecapableofmaintainingatemperatureof121±2.0
equippedwithathermometer,apressuregauge,aventcock,andarackadequatetoaccommodateatleast12testcontainersabovethewaterlevel.
MortarandPestle—Useahardened-steelmortarandpestle,madeaccordingtothespecificationsinFigure1.
Figure1.MortarandPestleforPulverizingGlass1
OtherEquipment—Alsorequiredare20.3-cm(8-inch)sievesmadeofstainlesssteel,includingtheNos.20,40,and50sieves,alongwiththepanandcover(seeSizesofStandardSieveSeriesinRangeofInterestunderParticleSizeDistributionEstimationbyAnalyticalSieving
786
);250-mLconicalflasksmadeofresistantglassagedasspecified;a900-g(2-lb)hammer;apermanentmagnet;adesiccator;andanadequatevolumetricapparatus.
Reagents—
High-PurityWater—Thewaterusedinthesetestshasaconductivityat25
asmeasuredinanin-linecelljustpriortodispensing,ofnotgreaterthan0.15µSpercm(6.67Megohm-cm).Theremustalsobeanassurancethatthiswaterisnotcontaminatedbycopperoritsproducts(e.g.,copperpipes,stills,orreceivers).Thewatermaybepreparedbypassingdistilledwaterthroughadeionizercartridgepackedwithamixedbedofnuclear-graderesin,thenthroughacelluloseestermembranehavingopeningsnotexceeding0.45µm.2Donotusecoppertubing.Flushthedischargelinesbeforewaterisdispensedintotestvessels.Whenthelowconductivityspecificationcannolongerbemet,replacethedeionizercartridge.
CarbonDioxide–FreeWater—ThisisPurifiedWaterthathasbeenboiledvigorouslyfor5minutesormoreandallowedtocoolwhileprotectedfromabsorptionofcarbondioxidefromtheatmosphere,orPurifiedWaterthathasaresistivityofnotlessthan18Mohm-cm.
MethylRedSolution(PowderedGlassTestandWaterAttackat121
)—Dissolve24mgofmethylredsodiuminPurifiedWatertomake100mL.Ifnecessary,neutralizethesolutionwith0.02Nsodiumhydroxide,oracidifyitwith0.02Nsulfuricacidsothatthetitrationof100mLofHigh-PurityWater,containing5dropsofindicator,doesnotrequiremorethan0.020mLof0.020Nsodiumhydroxidetoeffectthecolorchangeoftheindicator,whichshouldoccuratapHof5.6.
MethylRedSolution(SurfaceGlassTest)—Dissolve50mgofmethylredsolutionin1.86mLof0.1Msodiumhydroxideand50mLofethanol(96%)anddiluteto100mLwithPurifiedWater.Totestforsensitivity,add100mLofCarbonDioxide-FreeWaterand0.05mLof0.02Mhydrochloricacidto0.1mLofthemethylredsolution(thesolutionshouldbered).Notmorethan0.1mLof0.02Msodiumhydroxideisrequiredtochangethecolortoyellow.Colorchange:
pH4.4(red)topH6.0(yellow).
PowderedGlassTest
RinsethoroughlywithPurifiedWatersixormorecontainersselectedatrandom,anddrythemwithacurrentofclean,dryair.Crushthecontainersintofragmentsabout25mminsize,divideabout100gofthecoarselycrushedglassintothreeapproximatelyequalportions,andplaceoneoftheportionsinthespecialmortar.Withthepestleinplace,crushtheglassfurtherbystriking3or4blowswiththehammer.Nestthesieves,andemptythemortarintotheNo.20sieve.Repeattheoperationoneachofthetworemainingportionsofglass,emptyingthemortareachtimeintotheNo.20sieve.Shakethesievesforashorttime,thenremovetheglassfromtheNos.20and40sieves,andagaincrushandsieveasbefore.Repeatagainthiscrushingandsievingoperation.Emptythereceivingpan,reassemblethenestofsieves,andshakebymechanicalmeansfor5minutesorbyhandforanequivalentlengthoftime.TransfertheportionretainedontheNo.50sieve,whichshouldweighinexcessof10g,toaclosedcontainer,andstoreinadesiccatoruntilusedforthetest.
Spreadthespecimenonapieceofglazedpaper,andpassamagnetthroughittoremoveparticlesofironthatmaybeintroducedduringthecrushing.Transferthespecimentoa250-mLconicalflaskofresistantglass,andwashitwithsix30-mLportionsofacetone,swirlingeachtimeforabout30seconds,andcarefullydecantingtheacetone.Afterwashing,thespecimenshouldbefreefromagglomerationsofglasspowder,andthesurfaceofthegrainsshouldbepracticallyfreefromadheringfineparticles.Drytheflaskandcontentsfor20minutesat140
transferthegrainstoaweighingbottle,andcoolinadesiccator.Usethetestspecimenwithin48hoursafterdrying.
Procedure—Transfer10.00gofthepreparedspecimen,accuratelyweighed,toa250-mLconicalflaskthathasbeendigested(aged)previouslywithHigh-PurityWaterinabathat90foratleast24hoursorat121for1hour.Add50.0mLofHigh-PurityWatertothisflaskandtoonesimilarlypreparedtoprovideablank.Capallflaskswithborosilicateglassbeakersthatpreviouslyhavebeentreatedasdescribedfortheflasksandthatareofsuchsizethatthebottomsofthebeakersfitsnuglydownonthetoprimsofthecontainers.Placethecontainersintheautoclave,andcloseitsecurely,leavingtheventcockopen.Heatuntilsteamissuesvigorouslyfromtheventcock,andcontinueheatingfor10minutes.Closetheventcock,andadjustthetemperatureto121
taking19to23minutestoreachthedesiredtemperature.Holdthetemperatureat121±2.0
for30minutes,countingfromthetimethistemperatureisreached.Reducetheheatsothattheautoclavecoolsandcomestoatmosphericpressurein38to46minutes,beingventedasnecessarytopreventtheformationofavacuum.Cooltheflaskatonceinrunningwater,decantthewaterfromtheflaskintoasuitablycleansedvessel,andwashtheresidualpowderedglasswithfour15-mLportionsofHigh-PurityWater,addingthedecantedwashingstothemainportion.Add5dropsofMethylRedSolution,andtitrateimmediatelywith0.020Nsulfuricacid.Ifthevolumeoftitratingsolutionisexpectedtobelessthan10mL,useamicroburet.Recordthevolumeof0.020Nsulfuricacidusedtoneutralizetheextractfrom10gofthepreparedspecimenofglass,correctedforablank.Thevolumedoesnotexceedthatind
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- congtainersGlassusp660