MultivitaminTwoChamberAmpules 1.Formulations Chamber1: I.VitaminApalmitate.................................40mg 1.7Mio.i.u./g(BASF) VitaminEacetate(BASF).......................200mg VitaminD240Mio.i.u./g........................0.2mg Butylhydroxyto luene..............................2.6mg Butylhydroxyanisol.................................1.4mg Soluto lHS15[1]......................................4.0g LutrolE400[1].........................................2.0g
II.Water.....................................................70.0g III.Sodiumascorbatecrystalline....................2.2g Dexpanthenol(BASF)............................300mg Folicacid..............................................0.8mg Propyleneglycol[1]...............................30.0ml Chamber2: I.Thiaminehydrochloride(BASF)..............110mg Riboflavinphosphatesodium...................66mg Nicotinamide.......................................440mg Pyridoxinehydrochloride(BASF)..............44mg
II.Parabenes..............................................18mg Citricacid.............................................252mg Sodiumhydroxide,solution1molar.........2.4ml Hydrochloricacid,0.1molar....................8.0ml Waterforinjectables...............................9.6ml 2.Manufacturing Chamber1:HeatmixtureIto 60C,addslowlythewaterofthesame temperatureandmixwithsolutionIII.AdjustthepHto about7,pass nitrogen throughthesolutionandfillinampulesundernitrogen .Sterilize at120Cduring10min. Chamber2:DissolvethemixtureIinthebuffersolutionII,keepitduring 5minundernitrogen bubbles,filterthrougha0.2μmmembraneandfill inampulesundernitrogen .ThepH-valueisabout4.3. Chemical stability (Vitamin contents after 12 months at 20–25 C,HPLC)Vitamin A: .................................not determinedFolic acid:.................................................75%Dexpanthenol: ..........................................91%Vitamin B1:...............................................93%Vitamin B2:...............................................90%Nicotinamide:..........................................100%Vitamin B6: ...............................................97%Vitamin C: ................................................94%
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