Appearance Light yellow powder Assay 99%min Melting point 114℃min Moisture 0.5% max

Appearance White crystal Assay,HPLC 99%min 4-Carboxybenzaldehyde 0.5% max Terephthalic acid 0.5% max Others 0.5% max Melting point 114-117℃ IR Test Complie Dissolution 0.5G in 10ML Me-Oh Drying lost 0.5% max

Appearance Yellow or light yellow crystal Assay,GC 98%min Melting point 54-56℃ Moisture 0.5% max

"Appearance White crystal IR Confirm to reference standard Assay,by Titration 0.1 N NaOH/Dried basis 99.5-101% Melting point 149-153℃ Water content(By K.F) 0.5% max Loss on drying 0.5% max PH(1.0% aqueous) 4.2-5.0 Ultrviolet Absorbance(1.0M aqueous) A(260nm): 0.06Abs unit max A(280nm): 0.05Abs unit max Solubility(1.0M aqueous) Clear, colorless solution Heay metal 5ppm max Fe 5ppm max Ni 3ppm max "

Appearance White or off-white powder white powder Identification UV conform Conforms Organic nitrogenous Conforms Conforms Citrate Conforms Conforms Water Not more than 1.0% 0.38% water Not more than 0.002% Conforms Related impuries Related compound A:Not more than 2.0% 0.86% Individual:Not more than 0.5% 0.38% (Z)isomer Conforms Conforms Organicvolatile impuritise Conforms Conforms Assay Between98.0~102.0% 99.2%

Character White to off white crystalline powder, slightly soluble in alcohol and in methylene chloride, practically insoluble in water Identification A) IR spectrum is in accordance with the spectrum obtained with Irbesartan RS B) The retention time of the major peak in the chromatogram of the assay corresponds to Irbesartan RS. Water 0.5% max metals 0.002% max Residue on ignition 0.1% max Related substances(HPLC) USP Impurity A Any unidentified impurity Total impurity 0.2% max 0.1% max 0.5% max Organic volatile impurities Meets the requirements of USP Residual azide 10ppm max Assay 98.0~102.0%(calculated on anhydrous basis)

Appearance A white to off white solid Identification A.HPLC:RRT test solution is similar to RRT reference solution B.IR: similar to reference substance Specific rotation -8°~ -12° Chlorides Not more than 100ppm Loss on drying Not more than 2.0% Sulfated ash Not more than 0.1% metals Not more than 10ppm Related substances ALD3 Not more than 0.15% ALD2 Not more than 0.15% TK1-10 Not more than 0.15% TK1-9 Not more than 0.15% Any other individual impurity ≤0.10% Total impurities ≤1.0% Enantiomer Not more than 0.15% Acetates Not more than 3000ppm Residual solvents Methanol 3000ppm max Ethanol 5000ppm max Ethyl ethe 5000ppm max Isopropanol 5000ppm max Acetonitrile 410ppm max Dichloromethane 600ppm max Tert-butyl methyl ethe 5000ppm max Hexane 290ppm max Isopropyl ethe 5000ppm max Ethyl acetate 5000ppm max Tetrahydrofuran 720ppm max 1,4-Dioxane 380ppm max Toluene 890ppm max Assay 98.0~102.0%(on the dried basis)

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

White crystalline powder,99%min

Appearance White crystalline powder Assay 99.0-100.5%min Melting point 128-132℃ Specific optical rotation -15.7˚~-17.3˚ Residue on ignition 0.1% max Loss on drying 0.5%max metals 20ppm max Absence of reducing substance Accords with the specification Clarity and color of the solution Accords with the specification