Characters White or almost white powder, Hygroscopic Identification A: Conforms with reference Rf.(TLC) B: Conforms with reference Standard retention time.(HPLC) Water 7.5% max pH 9.0~11.0 Residue on ignition 1.0% max metals 0.003% max TLC Chromatographic purity 1.0% max Assay ≥910ug/mg(on anhydrous basis) Bacteria endotoxin ≤2.0EU/mg Solution clear degree and color Clear, not more than 3 bugle yellow Residual solvents Ethanol not more than 2000ppm Microbiological purity Not more than 1000 aerobic bacteria per 1g Not more than 100 fungi per 1g Absence of Escherichia coli per 1g

Appearance White crystalline powder Aspect of solution Clear and colorless Potassium 19.78~20.28% Chloride ≤100ppm metals(Pb) ≤20ppm Loss on drying ≤0.50% Assay（dry basis） ≥98.5%

Azilsartan 147403-03-0 阿齐沙坦 C25H20N4O5 99% 白色或类白色结晶粉末

Colorless or very light yello clear liquid,99.9%min

Appearance Pale yellow crystalline powder Assay,HPLC 98.5-101.5% Solubility Soluble in water Identification UV: the UV absorption of 0.001% solution in water exhibits a max at about 228nm IR:IR Spectrum in potassium bromide dispersion of sample should beconcerdant with that of working standard spectrum HPLC: Retention time of the sample should be concordant to the retention time of workting standard. Element analysis:Carbon, Nitrogen, Hydrogen Melting point 121℃ Specific optical rotation +39˚ Isomer 75%min Residue on ignition 0.1% max metals 20ppm max Water 1.0% max Related substances Single impurity: 0.5% max Total impurity: 1.0% max

Description white or almost white crystalline powder Identification(IR,HPLC) complies with the standard Solubility Free soluble in chloroform and in alcohol ，very slightly soluble in water. Specific rotation -56.0°～-60.0° Water max.0.3% Melting point About 257℃ Loose Density (g/cm3) 0.27～0.37 Tapped Density (g/cm3) 0.40～0.56 Residue on ignition max.0.1% Metals max.10ppm Particle size 90%≤10um 100%≤20um Any individual impurity max.0.5% 0.38% Total impurities max.1.0% 0.86% Assay (HPLC, based on drying) 98.5%～101.0% 99.7% Acetone Max.5000ppm complies Chloroform Max.60ppm complies THF Max.720ppm complies Dichloromethane Max.600ppm complies Toluene Max.890ppm complies Methanol Max3000ppm complies Organic volatile substances Meet the ICH requirements complies Storage:Preserve in tight containers, and store at controlled room temperature.

Identification A, B Specific Optical Rotation +107°～+112° Melting Point 206℃～218℃ Loss on Drying ≤1.0% Residue On Ignition ≤ 0.2% Residue Solvent Methanol≤ 3000 ppm Dichloromethane≤ 600ppm Ethyl acetate≤ 5000ppm Metals ≤ 0.002% Assay 97%～103.0% Grain Size 99%≤20μm

Appearance Grey or beige powder with special odor Identification A:Spectrophotometry:the main absorption is found in 250mm—256mm.the max absorption is found at 269—275mm. B:TLC:Position and colour of chromatogarm of principle spots obtainrd from test preparation correspond to the standard preparation. Loss on drying ≤8.0% Granularity 100%pass the 2#sieve Container capacity The container capacity should not be less than the Labelled amount;yhe capacity for the every container should mot be less than 98.0% of thr labelled amount. Potentcy The assay of Enramycin should be in 90.0%-110.0% of the labelled amount.

Appearance White or almost white crystalline powder Melting range 79~82℃ Acidity Should be consistent with the standard Residue on ignition ＜0.1% Chloride ＜0.01% Sulfate ＜0.01% metals ＜20ppm Loss on drying ＜0.5% Solubility Practically insolubility in water Soluble in dichloromethane Slightly solubility in ethanol Related substance Impurity A＜0.1% Impurity B＜0.1% Impurity C＜0.2% Any other impurity＜0.1% Total impurity＜0.5% Residual solvents Acetone＜0.5% Isopropyl alcohol＜0.5% Toluene＜0.089% Chloroform＜0.006% Assay On anhydrous basis: 98.0%`102.0%

Characters A white or almst white powder hygroscopic,soluble in about 1 part of water practically insoluble in acetone and in alcohol. Identification A.Kanamycin by TLC B.Melting point(≈235℃) C.Kanamyycin by ninhydrin test D.Reaction of sulphate PH 5.5 TO 7.5(1% w/v) Specific optical rotation +103° to 105°(1% w/v) Kanamycin B ≤4.0% Sulphate 23.0% to 26.0% Loss on drying ≤5.0%(60℃, ≤0.7Kpa,3h) Sulphated ash ≤0.5% Assay(dried substance) ≥670 IU/mg Abnormal toxicity Approved Pyrogens Approved sterility Approved Residual solvents Ethanol≤500ppm

White lustrous crystalline powder, 99%min

Appearance A white or almost white powder Identification Complies with the infrared absorptions of RS Clarity and color of the solution Should be clear and colorless Loss on drying 1.0% max Residue on ignition 0.1% max metal 10ppm max Related substance Single impurity: 0.1% max Total impurity: 0.3% max Isopropanol 2000ppm max Methanol 1500ppm max Assay 98%-102%