glatiramer acetate specific optical rotation

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... with a characteristic odor, tastelessIdentificationMeets the requirementsMelting point46~49°CSpecific Optical Rotation (C=1,Ethanol)+110~+120°Loss on Drying≤0.5 ... % Total impurities≤0.50% Cyclohexane≤0.388% Toluene≤30ppm Ethyl Acetate≤250ppm Total Microbial Count≤1,000 per/g Moulds and ...

... chloroform and easy in ethanol, ethyl acetate, insoluted in water.Colourless needle crystalsMelting point131~136C133CSpecific optical rotation+10°~+14°+13.5° [Identification] Chemical ...

... chromatogram of the standard preparation,as obtained in the AssayCompliedSpecific optical rotation-1.0°~+1.0°0.6°Melting point60-62°C61 ... polymer content ≤2.0% CompliedResidual of Cyclohexane ≤500ppmCompliedResidual of Ethyl Acetate ≤250ppmCompliedResidual of Toluene ≤20ppmCompliedMicrobiological data Total aerobic countNot more than ...

... drying0.20% Max0.04%Assay99.0~101.0% Max99.52%Specific optical rotation-1°~ +1°ConformsToluene30ppm Max<20ppmEthyl Acetate25ppm MaxUndetectedTotal Aerobic Counts1000cfu/g ...

... -162.CSolubility: The product is easily soluble in toluene, ethyl acetate, acetone, chloroform, chloroform, ethanol and the like, slightly soluble in ... alcohol.CompliesIdentificatioIRHPLC Conform ConformCompliesAppearance Of Solution Solution Is Clear≤BY7Complies4.Specific Optical Rotation(°)-17 — -20°-19.2°5.Related Substances(1.3