Sinoway Industrial Co., Ltd

Date: 13th May 2016
Hydrocortisone
Sinoway Industrial Co.,Ltd is a famous China hydrocortisone manufacturer and supplier,Website:http://www.sinoway-chem.com, welcome to buy GMP and EP hydrocortisone from us and check the price with us.Basic information:Product Name: HydrocortisoneMolecular Formula : C21H30O5Molecular Weight: 362.46CAS No.: 50-23-7Appearance: White crystalline powderSpecifications?EP6/USP37;EP8Usages :Treat for allergic dermatitis, eczema, neurodermatitis, seborrheic dermatitis, etc.Adrenocortical insufficiency and hypopituitarismItemsSpecificationsResultsAppearance (Ph. Eur.)A white or almost white, crystalline powderWhite crystalline powderSolubility (Ph. Eur.) (annual )Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chlorideCompliesIdentificationA: IR-spectrum (Ph. Eur.)Meets the requirementCompliesB: TLC (Ph. Eur.)Meets the requirementCompliesA: IR-spectrum (USP)Meets the requirementCompliesB: UV Absorption (USP)Meets the requirementCompliesSpecific optical rotation(Ph. Eur.)Between +150?and 156?+153.8?(USP)Between +150?and 156?+154.0?Loss on drying(Ph. Eur.)Not more than 1.0%0.07%(USP)Not more than 1.0%0.07%Residue on ignition (USP)Not more than 0.5%0.10%Related substances (Ph. Eur.)Any individual impurityNot more than 0.5%0.25%Sum of impuritiesNot more than 1.5%1.17%Chromatographic purity (USP)Any individual impurityNot more than 0.5%0.30%Sum of impuritiesNot more than 2.0%1.22%AssayUV Absorption (Ph. Eur.)Between 97.0% and 103.0%100.0%HPLC (USP)Between 97.0% and 102.0%99.8%Residual solvent (In-house)MethanolNot more than 500ppmNot detected outEthanolNot more than 2000ppm541ppmMethylene chlorideNot more than 600ppmNot detected outChloroformNot more than 60ppmNot detected outParticle size (In-house)90% not more than 15micronsCompliesConclusionThe product conforms to Ph.Eur.6/USP37ItemsSpecificationsResultsAppearanceA white or almost white, crystalline powderWhite crystalline powderSolubilityPractically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chlorideCompliesIdentificationA: IR-SpectrumMeets the requirementCompliesB: HPLCMeets the requirementCompliesSpecific optical rotationBetween+162?and +168?+165.4?Loss on dryingNot more than 1.0%0.09%Related substancesImpurity D RRT0.2Not more than 0.50%0.23%Impurity H RRT0.3Not more than 0.15%N.DImpurity I RRT0.5Not more than 0.50%0.17%Impurity M RRT0.7Not more than 0.10%0.09%Impurity G RRT0.8Not more than 0.40%0.08%Impurity E RRT0.86Not more than 0.50%0.09%Impurity A RRT0.96Not more than 0.20%0.09%Impurity B RRT1.1Not more than 0.20%N. DImpurity F RRT1.4Not more than 0.30%0.06%Impurity C RRT1.5Not more than 0.50%0.08%Impurity N RRT1.7Not more than 0.15%N.DAny unspecified impurityNot more than 0.10%CompliesSum of impuritiesNot more than 2.0%1.01%AssayBetween 97.0% and 103.0%100.7%Residual solvents (in-house)MethanolNot more than 500ppmNot detect outEthanolNot more than 2000ppmNot detect outMethylene chlorideNot more than 600ppmNot detect outChloroformNot more than 60ppmNot detect outParticle size (In-house )90% not more than 15micronCompliesConclusionThe product conforms to Ph.Eur. 8.0
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