ItemStandardAnalysis dataAppearanceWhite fine crystals or White powerconformsSpecific rotation(20/D)(C=4 in 6N HCL)-14.0 to -16.0°Degree-14.67°Chloride (Cl)Not more than 0.020%0.018%Heavy metals(Pb)Not more than 10ppm8ppmArsenic(As2O3)Not more than 1ppm<1ppmOther amino acidsChromatographically Not detectableconformsLoss on dryingNot more than 0.20%0.15%Residue on ignition(sulfated)Not more than 0.10%0.09%Assay98.0 to100.5%99.0%
ItemStandardAnalysis dataAppearanceWhite fine crystals or White powerconformsSpecific rotation(20/D)(C=4 in 6N HCL)-14.0 to -16.0°Degree-14.67°Chloride (Cl)Not more than 0.020%0.018%Heavy metals(Pb)Not more than 10ppm8ppmArsenic(As2O3)Not more than 1ppm<1ppmOther amino acidsChromatographically Not detectableconformsLoss on dryingNot more than 0.20%0.15%Residue on ignition(sulfated)Not more than 0.10%0.09%Assay98.0 to100.5%99.0%
ItemStandardAnalysis dataAppearanceWhite powderconformsState of Solution (Transmittance)Not less than 95.0%98.1%Chloride (Cl)Not more than0.02%<0.008%Heavy metal(Pb)Not more than 15ppm<15ppmArsenic(As2O3)Not more than 2ppm<2ppmLoss on dryingNot more than 0.20%0.18%Residue on ignition(sulfated)Not more than 0.20%0.11%Assay98.0 to101.0%99.0%
ItemsStandardAnalysis dataAppearanceWhite to off-white powderconformsSpecific Rotation [20/D](C=4 in CH3OH)+22º to +26º+24.6ºMelting point 187-190℃188℃Heavy Metals (Pb)Not more than 20 PPM<20ppmArsenic (As2O3)Not more than 2 PPM<2ppmLoss on DryingNot more than 0.50%0.11%Residue on IgnitionNot more than 0.2%0.06%AssayNot less than 98.5%99.3%
ItemsStandardAnalysis dataAppearanceWhite powderconformsSpecific Rotation [20/D](C=4 in methanol)-22.0 to -26.0°-24.2°State of Solution (Transmittance)Not less than 98.0%98.2%Heavy Metals (Pb)Not more than 20 PPM6ppmIron (Fe)Not more than 10ppm8ppmArsenic (As2O3)Not more than 2 PPM<2ppmChloride (Cl)Not more than 0.020%0.018%Loss on DryingNot more than 0.35%0.19%Residue on IgnitionNot more than 0.2%0.10%Assay98.0% to 102.0%99.0%
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