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VitaminBComplexInjectable Solution 1.Formulation I.Thiaminehydrochloride(BASF)...........1,100mg Riboflavinphosphatesodium.................660mg Nicotinamide.....................................4,400mg Pyridoxinehydrochloride(BASF)............440mg Cyanocobalamin....................................880μg EDTA,disodiumsalt................................20mg Propy1gallate.........................................50mg Kollidon17PF[1]......................................10g II.Parabenes............................................160mg Citricacid..........................................2,270mg SodiumhydroxideSolution 1molar........21.6ml Hydrochloricacid0.1molar...................72.0ml Propyleneglycol[1]...............................20.0ml WaterforInjectable s.............................86.4ml Totalamount................................about200ml 2.Manufacturing DissolvethemixtureIinthebufferSolution II,keepitduring5minunder nitrogen bubbles,filterthrougha0.2μmmembraneandfilltheclear yellowSolution inampoulesof2mlundernitrogen .ThepH-valueisabout 4. 3.Stability(20-25C,dark) ThefollowingvitaminlossesweredeterminedbyHPLC. Vitamin9Months12Months B18%11% B26%10% Nicotinamide0%0% B69%9% B1213%nottested
关键字:vitamin complex injectable
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