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%

Appearance Colourless or pale yellow, crystalline powder Identification IR absorption spectrum UV absorption spectrum Clarity and colour of solution 2.0% solution in 0.1M citric acid is clear. Sight than reference solution BY6. 5-Aminoimidazole-4-carbox amide hydrochloride 0.6% max Related Substances Any secondary peak 1.0% max The sum 3.0% max Loss on drying 0.5% max Sulphated ash 0.1% max Related compounds A: 1.0% max B: 1.0% max Volatils Organic Impurities Comply class 1,2&3 Bacterians Endotoxins Max 0,3 UE/mg Residual solvents Methanol : ≤3000ppm Assay 98.5~101.0%

Appearance White to slight yellow,crystalline powder Identification Complies Specific -75~~880 PH 2.6~~4.1 Water (K.F) 9.0~~12.0 Particle size distribution Informative Chromatographic purity Individual impurity ≤1.0 Total impurity ≤2.0 Residual solvent Acetone ≤0.5 Dichloromethane ≤600 Methanol ≤0.3 Assay (HPLC) 950~1030