VitaminA VitaminD3 VitaminE Beta CaroteneVeterinary Injectable Solution (100000i.u. 20000i.u. 10mg 8mg/g) 1.Formulation I.VitaminApropionate................................4.4g 2.5Mioi.u./g(BASF) VitaminD340Mioi.u./g..........................0.05g Benzylalcohol..........................................1.0g CremophorEL[1].....................................9.0g
II.WaterforInjectable s...............................72.3g III.VitaminEacetate....................................1.0g Butylhydroxyto luene.................................0.4g CremophorEL[1]...................................<9.0g
IV.Beta-Carotenecrystalline(BASF)...............0.8g 2.Manufacturing HeatmixtureIto 65C.HeatthewaterIIto 65Candadditslowlyto theheatedmixtureI.AclearSolution isformed(=MixtureI/II). HeatthemixtureIIIto 180C.Whenthetemperatureisreachedaddthe beta-caroteneIV,holdfor3minatthistemperatureandthenadd MixtureI/IIslowlyduringthenext4minutes.Letcoolundercontinuous stirringofabout30minutes.AclearSolution isformed. Aftertheampouleshavebeenheat-sterilized,theyshouldbeshakenfor ashorttime,whiletheyarestillhot,to eliminateanyseparationofthe phasesthatmayhaveoccurred.Sterilizationcanalsobeperformedby membranefiltrationunderpressure. 3.PropertiesoftheSolution Darkred-brown,clearSolution . 4.Remark InGermanyCremophorELmustbedeclaredonthepackageof Injectable s.
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