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AscorbicAcidInjection

Definition

AscorbicAcidInjectionisasterilesolutionofAscorbicAcidinWaterforInjectionscontainingSodiumBicarbonate.

TheinjectioncomplieswiththerequirementsstatedunderParenteralPreparationsandwiththefollowingrequirements.

Contentofascorbicacid,C6H8O6

95.0to105.0%ofthestatedamount.

Characteristics

Acolourlessliquid.

Identification

A.Carryoutthemethodforthin-layerchromatography,AppendixIIIA,usingasilicagelF254precoatedplate(Mercksilicagel60F254platesaresuitable)andamixtureof120volumesofethanol(96%)and20volumesofwaterasthemobilephase.Applyseparatelytotheplate2µlofeachofthefollowingsolutions.Forsolution(1)dilutetheinjection,ifnecessary,withwatertocontain0.5%w/vofAscorbicAcid.Solution(2)contains0.5%w/vofascorbicacidEPCRSinwater.Afterremovaloftheplate,allowittodryinairandexamineunderultravioletlight(254nm).Theprincipalspotinthechromatogramobtainedwithsolution(1)correspondstothatinthechromatogramobtainedwithsolution(2).

B.Toavolumecontaining50mgofAscorbicAcidadd0.2mlof2Mnitricacidand0.2mlof0.1Msilvernitrate.Agreyprecipitateisproduced.

Acidity

pH,5.0to6.5,AppendixVL.

Oxalicacid

Diluteavolumecontaining0.25gto5mlwithwater,neutralisetolitmuspaperwith2Msodiumhydroxide,add1mlof2Maceticacidand0.5mlofcalciumchloridesolutionandallowtostandfor1hour.Anyopalescenceproducedisnotmoreintensethanthatinasolutionpreparedatthesametimeandinthefollowingmanner.Dissolve70mgofoxalicacidin500mlofwaterandto5mloftheresultingsolutionadd1mlof2Maceticacidand0.5mlofcalciumchloridesolution(0.3%).

Assay

Toavolumecontaining0.2gadd5mlof2Msulphuricacidandtitratewith0.05MiodineVSusingstarchmucilageasindicator.Eachmlof0.05MiodineVSisequivalentto8.806mgofC6H8O6.

Storage

AscorbicAcidInjectionshouldbeprotectedfromlightandstoredatatemperatureof2°to8°.

WhenvitaminCinjectionisprescribedordem