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Oxytetracycline Injectable Solution for i.m. i.v.Veterinary Application (500mg/10ml) 1.Formulation I.0xytetracycline hydrochloride...................5.7g II.Kollidon17PF[1]...................................10.0g Reducingagent........................................0.5g (e.g.RongaliteC,BASF) WaterforInjectable s..........................ad100ml III.Magnesiumoxide...................................0.46g IV.Ethanolamine...........................to adjust pH8.8 2.Manufacturing Suspend IIIinSolution II,pass continously nitrogen through the Solution to avoidoxidationandaddslowlyIto thewellstirredSolution .adjust the pHwith IV. 3.PropertiesoftheSolution YellowclearSolution . 4.Remarks Theabsenceofoxygenduringmanufacturingandinthefinalpackaging andagoodqualityofOxytetracycline HClareessentialto avoidthe oxidation(=darkSolution ). ThefunctionofKollidon17PFnoto nlyisthesolubilisationofOxytetracycline butalsothereductionofitslocalto xicity. Thereducingagentmustbeselectedinaccordancewiththelegislation ofthecorrespondingcountry.
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