PEG-40氢化蓖麻油 美国药典标准

PEG-40氢化蓖麻油美国药典 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 NF30OfficialMonographs/Polyoxyl1917C:Toasolution(1in20)addbromineTS,dropwise:theCongealingtemperature〈651〉:between37°and47°.bromineisdecolorized.Acidvalue〈401〉:notmorethan2.Specificgravity〈841〉:between1.05and1.06.Hydroxylvalue〈401〉:between25and40.Viscosity〈911〉:between600and850centipoisesat25°,aSaponificationvalue〈401〉:between25and35.capillaryviscometerbeingused.Water,MethodI〈921〉:notmorethan3.0%.Acidvalue〈401〉:notmorethan2.0.Heavymetals,MethodII〈231〉:0.001%.Hydroxylvalue〈401〉:between65and80.Freepolyethyleneglycols—Transferabout6g,accuratelyIodinevalue〈401〉:between25and35.weighed,toa500-mLseparatorcontaining50mLofethylace-Saponificationvalue〈401〉:between60and75.tate.Dissolvecompletely,thenadd50mLofsodiumchloridesolution(29in100),shakevigorouslyfor2minutes,andallowWater,MethodI〈921〉:notmorethan3.0%.toseparatefor15minutes.Ifseparationisincomplete,carefullyResidueonignition〈281〉:notmorethan0.3%.inserttheseparatorintothewellofasteambathforshorttimeHeavymetals,MethodII〈231〉:0.001%.intervals.Repeatthistechniqueasmanytimesasnecessarytoensurethecompleteseparationofthetwophases.Cool,anddrainthelower,aqueous,phaseintoasecond500-mLseparator,andextracttheupperlayerwithasecond50-mLportionofsodiumchloridesolution(29in100).RepeatthePolyoxyl40HydrogenatedCastorOilseparationasbefore,includingthesteambathtechniquetoen-hancecompleteseparation.Tothecombinedaqueouslayers»Polyoxyl40HydrogenatedCastorOilcontainsadd50mLofethylacetate,shakevigorouslyfor2minutes,andmainlythetri-hydroxystearateesterofethoxy-allowtoseparateasbefore.Drainthelower,aqueousphaseintoathird500-mLseparator,andextractitwithtwo50-mLlatedglycerol,withsmalleramountsofpolyethyl-portionsofchloroform,byshakingfor2minuteseachtime.eneglycoltri-hydroxystearateandofthecorre-Repeatthesteambathtechniquetoensurecompletesepara-spondingfreeglycols.Itresultsfromthereactiontion.Evaporatethecombinedchloroformextractsina150-mLofglyceroltri-hydroxystearatewithabout40tobeakeronasteambath,withtheaidofastreamofnitrogen,toapparentdryness.Redissolveinabout15mLofchloroform,45molesofethyleneoxide.andtransfertoafilter,collectingthefiltrateina150-mLPackagingandstorage—Preserveintightcontainers.beaker.Rinsethefunnelwithseveralsmallportionsofchloro-form,andevaporatethecombinedfiltrateandrinsings,asde-Identification—scribedabove,untilnoodorofchloroformorethylacetateisA:Dissolveabout0.1gin1mLofwater,add9mLofperceptible.Dryinvacuumat60°for1hour.Coolinadesicca-sodiumchloridesolution(1in20),andheatinawaterbath:tor,andweigh:notlessthan17%andnotmorethan27%ofthesolutionbecomesturbidatatemperaturebetween70°andfreepolyethyleneglycolsisfound.85°.B:Dissolveabout0.1gin10mLofalcoholicpotassiumhydroxideTS,boilforabout3minutes,andevaporatetodry-ness.Mixtheresiduewith5mLofwater:itdissolves,yieldingaclearsolution.Addafewdropsofglacialaceticacid:awhitePolyoxylLaurylEtherprecipitateisformed.Congealingtemperature〈651〉:between16°and26°.CH3(CH2)11(OCH2CH2)nOH,n=3–23Acidvalue〈401〉:notmorethan2.0.Polyethyleneglycolmonolaurylether[9002-92-0].Hydroxylvalue〈401〉:between60and80.DEFINITIONIodinevalue〈401〉:notmorethan2.0.PolyoxylLaurylEtherisamixtureofthemonolaurylethersofSaponificationvalue〈401〉:between45and69.mixedpolyethyleneglycols,theaveragepolymerlengthbe-Water,MethodI〈921〉:notmorethan3.0%.ingequivalenttoNLT3andNMT23oxyethyleneunits(nominalvalue).Itcontainsvariousamountsoffreelaurylal-Residueonignition〈281〉:notmorethan0.3%.cohol,anditmaycontainsomefreepolyethyleneglycols.Heavymetals,MethodII〈231〉:0.001%.IDENTIFICATION•A.INFRAREDABSORPTION〈197F〉Sample:UseathinfilmofmeltedPolyoxylLaurylEtherifthematerialisasolid.Polyoxyl40StearateAcceptancecriteria:MeetstherequirementsPoly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy-,octade-•B.PROCEDUREcanoate.Sample:0.1gPolyethyleneglycolmonostearate[9004-99-3].Analysis:DissolveordispersetheSamplein5mLofalcohol,andadd10mLofdilutedhydrochloricacid,5mLofbarium»Polyoxyl40Stearateisamixtureofthemono-chlorideTS,and10mLofphosphomolybdicacidsolution(1estersanddi-estersofStearicAcidorPurifiedSte-in10).Acceptancecriteria:Aprecipitateisformed.aricAcidwithmixedpolyoxyethylenediols,the•C.ItmeetstherequirementsofthetestforFatsandFixedaveragepolymerlengthbeingequivalenttoOil,HydroxylValues〈401〉.about40oxyethyleneunits.IMPURITIESPackagingandstorage—Preserveintightcontainers.OrganicImpurities•PROCEDURE:LIMITOFFREEETHYLENEOXIDEANDDIOXANEUSPReferencestandards〈11〉—Analysis:ProceedasdirectedinEthyleneOxideandDiox-USPPolyoxyl40StearateRSane,MethodI〈228〉.Identification,InfraredAbsorption〈197M〉,onundriedspecimen.OfficialfromMay1,2012Copyright(c)2011TheUnitedStatesPharmacopeialConvention.Allrightsreserved.Accessedfrom128.83.63.20bynEwp0rt1onTueNov2923:32:55EST2011