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PropanidideInjectable Solution (50mg/ml) 1.Formulation I.Propanidide.............................................5.0g CremophorEL[1]...................................20.0g II.Preservatives.............................................q.s. WaterforInjectable s..........................ad100ml 2.Manufacturing MixpropanididewiththewarmCremophorEL(60C)andaddslowly thewarmSolution II.Thesterilisationcanbedonebyfiltrationorheat. 3.PropertiesoftheSolution AclearcolourlessSolution wasobtained. 4.Remarks –to reducetheviscosityandthesideeffects,CremophorELcouldbe substitutedbySoluto lHS15[1]. –InGermanyCremophorELmustbedeclaredonthepackageof Injectable s. –Duringtheheatsterilisationaseparationoftwolayerscanbeobserved. Shakingoftheampoulesduringcoolinggiveshomogeneous clearSolution s.
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