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 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 A white or almost white powder, hygroscopic Identification Very soluble in water, practically insoluble in ethanol A.TLC-test: principal spot should be as per ref. standard B. Reaction with ferric chloride: violet color develops C. Reaction with sodium hypochlorite: Red color develops D. Reaction with hydrochloric acid: faint yellow color develops E. Reaction of sulphate Appearance of solution Color: not more intense than ref. Sol. 3 Clarity: Not more opalescent than ref. suspension II PH 4.5-7.0 Methanol 0.3% max Streptomycin B 3.0% max Loss on drying 7.0% max Sulphated ash 1.0% max Sulphate 18.0%~21.5% Colorimetric test 90.0%min Assay(dried potency) 720 IU/mg min