ItemsStandardAnalysis dataAppearanceWhite crystals or crystalline powderconformsChloride (Cl)Not more than 0.020%0.017%Heavy Metals (Pb)Not more than 10PPM7PPMArsenic(As2O3)Not more than 1PPMconformsOther amino acidsNot detectedconformsLoss on DryingNot more than 0.20%0.13%Residue on Ignition (Sulfated)Not more than 0.10%0.09%Assay98.0%~101.0%99.1%PH5.0~6.05.7
ItemsStandardAppearanceWhite crystal or white crystalline powderSpecific Rotation [20/D] (C=2 in H2O)+46.5° to +49.0° TransmittanceNot less than 96.0%Chloride (Cl)Not more than 0.020%Ammonium (NH4)Not more than 0.02%Sulfate (SO4)Not more than 0.020%Iron (Fe)Not more than 30ppmHeavy metal(Pb)Not more than 10ppmArsenic(As2O3)Not more than 2ppmOther amino acidsChromatographically Not detectableLoss on dryingNot more than 0.5%Residue on ignition(sulfated)Not more than 0.1%Assay98% to102%pH2.0 to 3.0
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 crystalline powderconformsSolubility (10% NaOH)Clearconforms Melting Point (℃)204 to 209℃206℃Loss on DryingNot more than 0.35%0.15%Residue on IgnitionNot more than 0.1%0.08%Assay98.0% to 102.0%99.0%
ItemStandardAnalysis dataAppearanceWhite crystalline powderConformsSpecific rotation[α]20/D(C=8 6N HCL )+16.5 to ~18.5 Degree 17.0°Transmittance(0.5 in 10ml of H2O)Not less than 95.0%96.0%Chloride (Cl)Not more than 0.020%<0.02%Ammonium (NH4)Not more than 0.02%<0.02%Sulfate (SO4)Not more than 0.020%<0.02%Iron (Fe)Not more than 10ppm<10ppmHeavy metal(Pb)Not more than 10ppm<10ppmOther Amino AcidsChromatographically Not detectableConformsLoss on dryingNot more than 2.0%<1.6%Residue on ignition(sulfated)Not more than 0.10%0.10%Assay 98.5%~101.5%(dried dample90mg, 3mL of fomic acid,50mL of glacial acetic acid,0.1N HClO4 1mL=9.310mg C10H21N3O6)99.0%
ItemStandardAnalysis dataAppearanceWhite crystalline powderConformsSpecific rotation[α]20/D(C=8 6N HCl)+28.0 to ~30.0Degree 28.18°TransmittanceNot less than 98.0%98.1%Chloride (Cl)Not more than 0.020%0.018%Ammonium (NH4)Not more than 0.02%<0.02%Sulfate (SO4)Not more than 0.030%0.008%Iron (Fe)Not more than 10ppm<10ppmHeavy metal(Pb)Not more than 10ppm<10ppmArsenic(As2O3)Not more than 1ppm<1ppmOther Amino AcidsChromatographically Not detectableConformsWaterNot more than 5.0%2.15%Residue on ignition(sulfated)Not more than 0.20%0.10%Assay98.5%~101.0%98.88%PH6.0 to 7.56.8
ItemStandardAnalysis dataAppearanceWhite crystals or crystalline powderconformsTransmittanceNot less than 95.0%9635%Specific Rotation [25/D] (C=3 in water at 25 ºC)-11.5º to -13º-11.55ºChloride (Cl)Not more than 0.04%<0.04%Ammonium(NH4)Not more than 0.01%<0.01%Sulfate (SO4)Not more than 0.048%<0.04%Iron(Fe)Not more than 30ppm<30ppmHeavy Metal(Pb)Not more than 10ppm<10ppmArsenic(As2O3)Not more than 2ppm<2ppmLoss on dryingNot more than 0.50%0.25%Residue on ignition(sulfated)Not more than 0.2%0.04%Assay98.0% to 101.0%98.5%
ItemsStandardAnalysis dataAppearancewhite crystalline powderconformsOptical rotation+16°~ +20°+19.36°Solubilitycolorless transparentconformsWaterNot less than 0.5%0.3%AssayNot less than 98%99.1%
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%
ItemStandardAnalysis dataAppearanceWhite crystals or crystalline powderconformsSpecific rotation[α]20/D(C=2,H2O)-14.0°to-17.0°-15.25°TransmittanceNot less than 95.0%98.1%Heavy metal(Pb)Not more than 20ppm<10ppmIron (Fe)Not more than 10ppm8ppmArsenic(As2O3)Not more than 2ppm<2ppmChloride (Cl)Not more than 0.020%0.02%Sulfate (SO4)Not more than 0.10%0.005%Other amino acidsChromatographically not detectableconformsLoss on dryingNot more than 0.50%0.10%Residue on ignitionNot more than 0.30%0.098%Assay98.0to102.0%99.5%pH1.7to2.82.2ConclusionThe product is according with standard.
ItemStandardAnalysis dataAppearanceWhite crystal powderconformsSpecific rotation[α]20/D(C=2 in H2O)61 to67Degree 65.8 DegreeLoss on dryingNot more than 0.5%0.3%Assay98.0to102.0%98.8%
ItemStandardAnalysis dataAppearanceWhite crystals or crystalline powderConforms Specific Rotation [20/D] (C=1 in H2O)+25.8 ° to +27° +26.0°Loss on dryingNot more than 0.50%0.26%Assay98.5to101.0%98.8%
ItemStandardAppearanceWhite fine crystalsSpecific Rotation [20/D] (C=1 in H2O)+21±1 Degree IR SpectrumIn accordance with structureMelting Point (Celsius Degree)100 to 106 Celsius DegreeLoss on dryingNot more than 0.50%Assay98.0to102.0%
ItemsStandardAnalysis dataAppearanceWhite crystals or crystalline powderconformsSpecific rotation[α]20/D(C=1 Acetic acid)+9.3°+ 2°8.14°Melting point 159 to 168℃160℃Heavy metal(Pb)Not more than 20ppm<20ppmArsenic (As2O3)Not more than 2ppm<2ppmLoss on DryingNot more than 0.50%0.18%Residue on ignitionNot more than 0.30%0.1%Assay98.0% to 102%98.6%
ItemsStandardAnalysis dataAppearanceWhite crystals or crystalline powderconformsSpecific rotation[α]20/D(C=1 Acetic acid)+9.3°+ 2°8.14°Melting point 159 to 168℃160℃Heavy metal(Pb)Not more than 20ppm<20ppmArsenic (As2O3)Not more than 2ppm<2ppmLoss on DryingNot more than 0.50%0.18%Residue on ignitionNot more than 0.30%0.1%Assay98.0% to 102%98.6%
ItemStandardAnalysis dataAppearanceWhite powderconformsSpecific rotation[α]20/D(C=2 in water)-64±3 °-63.2°TransmittanceNot less than 95.0%96.8%Melting Point123-129 ℃123.5 ℃ Arsenic(As2O3)Not more than 2ppmconformsLoss on dryingNot more than 0.50%0.36%Residue on ignitionNot more than 0.30%0.21%Assay98.0to102.0%99.0%
ItemStandardAnalysis dataAppearanceWhite crystals or crystalline powderconformsSpecific rotation[α]20/D(C=2,H2O)+14.0°to+17.0°+15.5°TransmittanceNot less than 95.0%98.0%Heavy metal(Pb)Not more than 20ppm<10ppmArsenic(As2O3)Not more than 2ppm<2ppmOther amino acidsChromatographicallynot detectableconformsLoss on dryingNot more than 0.50%0.3%Residue on ignitionNot more than 0.30%0.2%Assay98.0to102.0%99.3%pH1.7to2.82.3
ItemStandardAnalysis dataAppearanceOff-white crystal powderconformsDL-TyrNot more than 1.0%conformsAssay98.0 to101.0%99.7%ConclusionThe product conforms to the standard.
ItemsStandardAnalysis dataAppearancewhite powderConformsSpecific Rotation-14.5º- -15.5º-15.4ºAssay99.0%-101.0%99.80%Transmittance≥95 %98.5 %Loss on drying≤0.20%0.10%Residue on Ignition≤0.10%0.09%Arsenic(AS2O3)≤1ppm<1 ppmHeavy Metals(Pb)≤10ppm<10ppmPH5.2-6.25.82Chloride ( Cl)≤0.02%<0.02%Sulfate (SO4)≤0.02%<0.02%Iron( Fe)≤10ppm<10ppmAmmonium(NH4)≤0.02%<0.02%Isomer purity≤0.1%<0.1%
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