PrednisoloneBaseCASNo:50-24-8Standard:EP/USP/BPModelNO.:50-24-8Appearance:WhiteoralmostWhitecrystallinepowderSpecificOptical:+167-+175Rotation:169Identification:PositiveProductdescription:Prednisoloneisasteroid.Itpreventsthereleaseofsubstancesinthebodythatcauseednisoloneisusedtotreatmanydifferentconditi***suchasallergicdisorders,skinconditi***,ulcerativecolitis,arthritis,lupus,psoriasis,orbreathingdisorders.Prednisolonemayalsobeusedforpurposesnotlistedinthismedicationguide.Prednisoloneisasyntheticadrenalcorticosteroid.Corticosteroidsarenaturalsubstancesproducedbytheadrenalglandslocatedadjacenttothekidneys.Corticosteroidsh***epotentanti-inflammatoryproperties,andareusedinawidevarietyofinflammatoryconditi***suchasarthritis,colitis,asthma,bronchitis,certainskinrashes,andallergicorinflammatoryconditi***ofthenoseandeyes.Therearenumerouspreparati***ofcorticosteroidsincludingtablets,capsules,liquids,topicalcreamsandgels,inhalers,eyedrops,aswellasinjectableandintr***enoussoluti***.TheFDAapprovedprednisoloneinJune1955.Prednisoloneisusedtoachievepromptsuppressionofinflammationinmanyinflammatoryandallergicconditi***.Examplesofinflammatoryconditi***includerheumatoidarthritis,systemiclupus,acutegoutyarthritis,psoriaticarthritis,ulcerativecolitis,andCrohn'sdisease.Severeallergicconditi***thatfailconventionaltreatmentmayalsorespondtoprednisolone.Examplesincludebronchialasthma,allergicrhinitis,drug-induceddermatitis,andcontactandatopicdermatitis.Chronicskinconditi***treatedwithprednisoloneincludedermatitisherpetiformis,pemphigus,severepsoriasisandsevereseborrheicdermatitis.Chronicallergicandinflammatoryconditi***oftheuvea,iris,conjunctivaandopticnervesoftheeyesarealsotreatedwithprednisolone.Prednisolonealsoisusedinthetreatmentofbloodcellcancers(leukemiias),andlymphglandcancers(lymphomas).Blooddiseasesinvolvingdestructionofplateletsbythebody'sownimmunecells(idiopathicthrombocytopeniapurpura),anddestructionofredbloodcellsbyimmunecells(autoimmunehemolyticanemia)canalsobetreatedwithprednisolone.Othermiscellaneousconditi***treatedwithprednisoloneincludethyroiditisandsarcoidosis.Prednisoloneisalsousedasahormonereplacementinpatientswhoseadrenalglandsareunabletoproducesufficientamountsofcorticosteroids.COAofthePrednisoloneProductnamePrednisoloneAppearanceWhitecrystallinepowderChromatographicpurityAnyindividualimpuritynotmorethan1.0%Totalimpuritiesnotmorethan2.0%0.5%1.2%LossondryingNotmorethan0.5%0.25%ResidueonignitionNotmorethan0.2%0.06%ResidualsolventsMethanol¡Ü3000ppmMethyleneChloride¡Ü600ppmChloroform¡Ü60ppmTetrahydrofuran¡Ü720ppm400ppmNotdetectoutNotdetectoutNotdetectoutAssayBetween97.0%and102.0%99.1%Micronixation90%notmorethan10micr***90%notmorethan10aicr***)