Sinoway Industrial Co., Ltd

Date: 13th May 2016
Hydrocortisone Acetate
Sinoway Industrial Co.,Ltd is a famous China hydrocortisone acetate manufacturer and supplier,Website:http://www.sinoway-chem.com, welcome to buy GMP and EP hydrocortisone acetate from us and check the price with us.Basic information:Product Name: Hydrocortisone AcetateMolecular Formula : C23H32O6Molecular Weight: 404.5CAS No.: 50-03-3Appearance: White crystalline powderSpecifications?EP8; EP6/USP37Usages :1)Eczema, itchy skin, neurodermatitis, seborrheic dermatitis, ?allergic dermatitis, pruritus2)Allergic conjunctivitisItemsStandardsResultsCharactersA white or almost white, crystalline powderWhite crystalline powderSolubility(annual)Practically insoluble in water, slightly soluble in anhydrous ethanol and in methylene chlorideCompliesIdentificationIR-spectrumHPLCMeets the requirementMeets the requirementCompliesCompliesSpecific optical rotationBetween +158?And +167?+164.3?Loss on dryingNot more than 0.5%0.12%Related substancesImpurity A RRT0.4Not more than 0.4%0.07%Impurity B RRT0.7Not more than 0.3%N. DImpurity C RRT0.9Not more than 0.6%0.08%Impurity D RRT1.2Not more than 0.3%0.05%Impurity G RRT1.8Not more than 0.15%N. DImpurity E RRT2.3Not more than 0.3%N. DAny unspecified impurityNot more than 0.10%CompliesTotalNot more than 1.0%0.39%Residual solvent( in-house )EthanolDMFNot more than 2000ppmNot more than 880ppm405ppmNot detect outAssayBetween 97.0% and 103.0%99.1%Particle size(In-house )90% not more than 20 micronsCompliesConclusionThe product conforms to Ph.Eur.8ItemsStandardsResultsCharactersA white or almost white, crystalline powderWhite crystalline powderSolubility(annual)Soluble in anhydrous ethanol and in methylene chlorideCompliesMelting point(Ph.Eur)About 220?220?IdentificationIR-spectrum(Ph.Eur)TLC(Ph.Eur.)A.IR-spectrum(USP)B.TLC(USP)Meets the requirementMeets the requirementMeets the requirementMeets the requirementCompliesCompliesCompliesCompliesSpecific RotationPh.EurBetween +158?and +167?+163.7?USPBetween+158?and +165?+164.0?Loss on drying(Ph.Eur.)(USP)Not more than 0.5%Not more than 1.0%0.11%0.03%Residue on ignition(USP)Not more than 0.5%0.35%Related substances(Ph.Eur)Any individual impuritySum of impuritiesNot more than 1.0%Not more than one such peak has an area greater than 0.5%Not more than 1.5%0.32%Complies0.78%Chromatographic purity(USP)Any individual impuritySum of impuritiesNot more than 1.0%Not more than 2.0%0.35%0.88%Residual solvent( in-house )MethanolChloroformPyridineDMFNot more than 500ppmNot more than 60ppmNot more than 200ppmNot more than 880ppmNot detect outNot detect outNot detect out703ppmAssayPh.Eur.USPBetween 97.0% and 103.0%Between 97.0% and 102.0%100.9%97.6%Particle size90% not more than 20 micronsCompliesConclusionThe product conforms to Ph.Eur.6/USP37
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