analytical report- pentobarbital - sedation - home：分析报告-戊巴比妥钠镇静-首页

《analytical report- pentobarbital - sedation - home：分析报告-戊巴比妥钠镇静-首页》由会员上传分享，免费在线阅读，更多相关内容在应用文档-天天文库。

1、ANALYTICALREPORT-PENTOBARBITALIntroduction-ToexplorethestabilityofdilutedpentobarbitalsolutioninD5Watroomtemperatureandhumidity.Figure1PentobarbitalChemicalStructure-Note:Thealkyltailisthepotentialsiteofinstabilityforthisdrug.Supplies:Nembutol®SodiumSolution20mg/ml20mlvialOvationPharmaceuticalsIncL

2、ot562453FExpSept2010PentobarbitalsodiuminjectioncontainsthefollowingingredientsEachmilliliterofsolutioncontains:PentobarbitalSodium50mgPropyleneGlycol40%(v/v)Alcohol10%Hydrochloricand/orSodiumHydroxideAdjustpHWaterforinjectionQSD5WInjection1000mlViaflexbagBaxterHealthcareLotC772590Exp10/2010Procedu

3、re:(a)Tomakea10mg/mlsolutionofa50mg/mlsolutionusea1:5dilutionor1mlinto5mlsofTOTALsolution.(b)Tomakea20mg/mlsolutionofa50mg/mlsolutionusea2:5dilutionor2mlsinto5mlsofTOTALsolution.Dilute1/100tobeabletoperformtheUVRemoveatvariousintervalsandobservethedeclineinconcentration.REFERENCEDATA:STABILITY-(Tri

4、ssel’s15thEdition)“Aqueoussolutionofpentobarbitalarenotstable.Thecommerciallyavailablepentobarbitalsodiuminapropyleneglycolvehicleismorestable.Inacidicmedia,pentobarbitalmayprecipitate.Nosolutioncontainingaprecipitateorthatiscloudyshouldbeused.”Syringes:(Trissel’s15thEdition):“Undilutedpentobarbita

5、l(Abbott)50mg/mlwaspackagedin1mlglassandPolypropylenesyringesand3mlpolypropylenesyringes(Becton-Dickinson)andstoredat25C.NOpentobarbitalsodiumlossbyHPLCanalysisoccurredin31days.4PentobarbitalStabilityTA8/26/09EXPERIMENTALRESULTS:Figure2UVscanofPentobarbital50mg/mldiluted1/100inSterileWater.TheUVsca

6、nofpentobarbitalisseeninfigure2.Pentobarbitalexhibitsapeakat240nmwhichcanbeusedastheλmeasured.Solutionsweremadeat20mg/mland10mg/mlindextrose5%waterandweremeasuredat15minuteintervals.Theresultsreportedwerethecalculatedconcentrationsusingtheinjection(50mg/ml)diluted1/100asthestandard.Theresultsforeac

7、hanalysisweredeterminedinduplicate.Table1summarizestheresultsfortheroomtemperaturestabilityofpentobarbital.Figure3illustratesthestabilityofPentobarbitalat10and20mg/mlconcentrationsofthedilutedinjectioninD5W