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PharmaceuticalanalysisIdentificationofglucoseandsodiumchlorideinjectionIdentificationofglucoseandsodiumchlorideinjectionAuthor:(TangYueping)1.IntroductionGlucoseandsodiumchlorideinjectionismainlyusedtoreplenishheatandbodyfluids.Itisapplicabletoinsufficientintakeoffoodandlossofplentyofbodyliquids.Glucoseisamainheatsourceofbody.Sodiumandchlorineareimportantelectrolytesinthebody.Theyexistinextracellularfluid,andplayaveryimportantroleinmaintainingthenormalvolumeandosmoticpressureofbloodandextracellularfluid.2.StructureandpropertyStructuralformulaofglucoseChemicalformulaofsodiumchloride:NaCl2.StructureandpropertyPropertyofglucose: OpticalactivitySincethestructurecontainsseveralchiralcarbonatomswithpropertyofchiralmolecule,ithasoptimalactivity. ThespecificrotationofD-glucoseinlightof20℃is+52.50-+53.00.2.Structureandproperty(1)Propertiesofglucose:
ReducibilityInaqueoussolution,itismainlyintheringstructureofhemiacetal.Afteraddedwithweakoxidant,thealdehydegroupinthemoleculehasreducibility,whichcanbeoxidizedtogluconicacidwithsilverammoniasolution,generatingprecipitate.CH2OH(CHOH)4CHO+2Ag(NH3)2OH→CH2OH(CHOH)4COONH4+2Ag↓+3NH3+H2O2.Structureandproperty(2)Propertiesofsodiumchloride:Chloridereaction Cl-producedbydissociationofsodiumchlorideinaqueoussolutioncanreactwithsilvernitratetoproducewhitesilverchlorideprecipitate,whichisinsolubleindilutenitricacid,butsolubleinaqueousammoniasolution.NaCl+AgNO3—→AgCl↓—→whiteprecipitatedissolvesReactionofsodiumsalt Na+presentsbrightyellowflamewhenburningcolorlessflameNH3·H2ODiluteHNO3
PartIIofChinesePharmacopeia(2020)QualitystandardofglucoseandsodiumchlorideinjectionAppearanceandshape:Thisproductiscolorlessandclearliquid.Identificationtest:GenerateredprecipitatewhenreactingwithFehlingreagent.Routineinspectionofpreparations:loadingquantity,pH,heavymetal,5-hydroxymethylfurfural,sterility,endotoxin,heatsource,etc.Contentdetermination:Glucose,sodiumchlorideAccordingtoprovisioninChinesePharmacopoeia(2020),bothglucose(C6H12O6▪H2O)andsodium(NaCl)shouldbe93.0%-107.0%ofthelabelledamount.3.Testandreagent2%dextrinsolution,2.5%boraxsolution,fluorescentyellowreagent,silvernitrate,standardleadstocksolution,dilutecaramelsolution,limulusamebocytelysate,hydrochloricacid,dilutenitricacidpotassiumhydrogenphthalate,sulfosalicylicacidsolution(1→5)3ml,5%glucosesodiumchlorideinjection,silvernitratetitrant(calibratetheconcentrationto0.1026mol/Lwithreferencesodiumchloride)4.TesterPrecisionaciditymeter,ultraviolet-visiblespectrophotometer,25mlNesslertube,WWZ-2opticalrotationtester,platinumwire,acidburette,ZDY-1automaticpotentiometrictitrator,AB256-Selectronicanalyticalbalance.5.TestcontentsThisproductisasterilizedaqueoussolutioncomposedofglucosemonohydrateandsodiumchloride.AllinformationofthepreparationshouldmeetprovisionsofthePharmacopoeia.Name,approvalNo.,specification,productionbatchNo.,validityperiod,manufacturer,contactinformation,etc.(1)PackagingandspecificationThisproductiscompoundpreparationofcolorlessandclearliquid.(2)Appearanceandproperty6.ExperimentstepsGlucoseisreducingsugarandreactswithcopperhydroxide:CH2OH(CHOH)4CHO+2Cu(OH)2→CH2OH(CHOH)4COOH+Cu2O↓+2H2O(1)Identificationofglucose(cuprousoxide)1)IdentificationofchlorideCl-+Ag+→AgCl↓(white)→DiluteHNO3
AmmoniumhydroxidePrecipitateinsolublePrecipitatesoluble2)IdentificationofsodiumsaltFlametest:brightyellowflame7.OriginalrecordsandresultsoftestTestdate____Temperature______Relativehumidity_______;Nameoftestproduct______Doseform______Specification________;Manufacturer_____BatchNo._____Validity________;Testbasis________Testpurpose______;I.Appearanceandproperty:Standardprovision:Testresult:II.Identificationtest:Standardprovision:Testresult:8.TestreportofmedicineNameoftestproductManufacturerDoseformSpecificationBatchNo.ValidityPackingInspectednumberTestpurposeTestitemTestdateReportdateTestbasisTestconclusion:8.TestreportofmedicineBackPowerbuttonLightsourcebuttonMeasuringbuttonRetestingbuttonResettingbutton8.TestreportofmedicineDeterminationtube8.TestreportofmedicineJanuary29,2021Settingpositionofdeterminationtube8.TestreportofmedicineFrontView8.TestreportofmedicineJanuary29,2021TopviewWavelengthscaleWavelengthadjustingbutton8.TestreportofmedicineJanuary29,2021AbsorptionchamberAbsorptioncellrod8.TestreportofmedicineAbsorptionchamberAbsorptionrackShapingcup8.TestreportofmedicineJanuary29,2021BackElevationPowerswitch
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