BP/EP/USP，99%

Description A white or almost white crystalline powder Identification Conform with spectrum off the reference standard Enantiomer ≤0.50% Related substance 5-Flucytosine ≤0.20% Total impurities ≤1.0% Residual solvents Ethanol ≤0.50% Dichloromethane ≤0.06% DMF ≤0.088% Ethyl acetate ≤0.50% Toluene ≤0.089% Residue on ignition ≤0.20% Specific optical rotation -133゜～-143゜ Water ≤0.50% Metal ≤20ppm Loss on drying ≤1.0% Assay 98.0%-102.0%

Assay 99% Boiling point 528.7 oC at 760 mmHg Appearance White villous crystallization

Appearance White or yellowish white ，crystalline powder or colourless or almost colourless crystals Solubility Slightly soluble in water ，very slightly soluble in ethanol（96%）.It is freely soluble indilute mineral acids. Identification A．IR IR spectrum is concordant with Methyldopa CRS. B.Enantiomeric purity D-Methyldopa not more than 0.5% Appearance of solution Not more intensely coloured than reference solution BY6 or B6. Acidity (0.1M NaOH) Not more than 0.5ml/g. Absorbance(on anhydrous basis) 122~137 Related substances Impurity A Not more than 0.15% Impurity B Not more than 0.15% Impurity C Not more than 0.15% Unspecified impurities Not more than 0.05% Total impurities Not more than 0.5%

Appearance White or pale yellow amorphous powder Solubility Practical insoluble in water,very soluble in ethanol(96%),slightly soluble in hexane Identification Conforms Appearance of solution Clear,color ≤GY5 Related Substances Method A Impurity A ≤1.5% Impurity B ≤0.5% Impurity C ≤1.5% Impurity D ≤2.5% Impurity E+F ≤1.7% Impurity G ≤1.5% Impurity L ≤0.5% Any other individual impurity before impurity G ≤0.5% Method B Impurity H+I ≤1.0% Impurity J ≤0.5% Impurity K ≤0.5% Any other individual impurity after impurity G ≤0.5% Total impurity ≤7.0% metals ≤ 20ppm Water ≤ 1.3% Sulphated Ash ≤0.2% Assay(on the anhydrous basis) 92.0%~~102.0% Antioxidant Assay 0.3%~~0.6% Residual Solvents Methanol ≤3000ppm Ethanol ≤5000ppm Dichloromethane ≤600ppm Propenol ≤50ppm Triethylamine ≤320ppm N-Heptane ≤5000ppm Methylcyclohexane ≤1180ppm 1,4-Dioxane ≤380 Butyl Ac3tate ≤5000ppm Dinethyl Sulfixide ≤5000ppm

Appearance Yellow amorphous powder Solubility Freely soluble in water, sparingly soluble in dimethylformamide, insoluble in ethanol(96 percent V/V) Identification A. Infrared absorption B. HPLC Appearance of solution Clarity ≤1# Color 80mg/ml, ＜BY3 or B4 Acidity or alkalinity 6.5~7.5 Composition and related substances Teicoplanin A2 group ≥80.0% Teicoplanin A2-2 35.0~55.0% Teicoplanin A2-1 group ≤20.0% Teicoplanin A2-3 group ≤20.0% Teicoplanin A2-4 ≤20.0% Teicoplanin A2-5 group ≤20.0% Teicoplanin A3 group ≤15.0% Total of impurities ≤5.0% Impurity A 0.2% max Residual solvents Ethanol ≤5000ppm Acetone ≤5000ppm Acetaldehyde ≤2000ppm Propionaldehyde ≤2000ppm Sodium chloride 5.0% max metals 20ppm max Water 15% max Sterility Conform Bacterial endotoxins ＜0.31 EU/mg Potency (dried substance) ≥900 IU/mg

Appearance White powder Identification Positive Specific rotation -11.0°~ -13.0° Assay 95.0~101.0% 1,2-Dihydroxyipopyiphosphonate ≤1.5% Alkalinity(PH) 8.1~9.6 Water 8.5~11.5 metals ≤20ppm Chloride ≤0.2%

Appearance White or almost white powder Identification Color reaction: The test solution obtain colorless, the blank solution abtion orange Color reaction: The solution obtain blue Sodium salt reaction: White precipitate generated Assay, on dry base 95%-101% PH 9.0-10.5 Specific optical rotation -5.5~-4.2˚ Water, K.F 1.0% max metals(ppm) 10ppm max Impurity A 1.0% max

Appearance A White Crystalline powder Assay,on dry base 98.5%-101.5% Solubility Soluble in methanol，insoluble in chloroform Melting point range 148.0 -156.0 ℃ Indentification A:Infrared Absorption B:The retention time of the major peak in HPLC C:The test for Oxalate A:The assay should accord with regulation B:The assay should accord with regulation C:It should meets the for Oxalate Loss on drying Not more than 1.0% metal Not more than 10ppm Residue on ignition Not more than 0.1% Specific Rotation +10.0～+14.0(in 0.05g/ml Methanol) R-isomer 1.0% max PH（in 0.01g/ml water） 2.0~4.0 Residual Sovents Terahydrofuram not more than 0.072% Toluene not more than 0.089% Any impurity peak Total impurities Any impurity peak: 0.1%max Total impurities: 0.5% max TLC Purity No secondary spot

Appearance Yellow crystalline powder Identification (1),(2),(3) should comply PH 2.0-3.0 Specific Absorbance 300~335 at 349nm Specific optical rotation -105°~ -120° Light absorbing impurities 0.07 max at 490nm Related substances (1)β-epidoxycycline ≤2.0% (2) melacycline ≤2.0% (3) Any other impurity ≤0.5% Ethanol 4.3-6.0% metals 50ppm max Sulphate ash 0.4% max Water 1.4~2.8% Assay 88.0-94.0% based on anhydrous ethanol-free substance

Appearance White or almost white crystalline powder Purity(HPLC) 99% min

Appearance White powder Identification Positive Loss on drying ≤5.0% Assay ≥98%