Density:1.704g/cm3 Application:Pharmaceutical Raw Material

Appearance: White or almost white crystalline powder Assay( On the dried basis ):98.0%~102.0%

Assay: ≥99% Appearance: white or off-white crystals powderDensity:1.43 g/cm3 Melting Point:157-159 °C Boiling Point:529 °C at 760 mmHg Flash Point:273.7 °C Appearance:white to pale yellow solid

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 White or almost white crystalline powder Purity(HPLC,basis on drying) 97.0~102.0% Identification (A,B) A:IR B:UV Specific Rotation +72°~+80° Loss on drying 0.5% max Residue on ignition 0.2% max Chromatographic purity Any individual impurity 1.0% max Total impurities 2.0% max Organic volatile substances Methanol ≤3000ppm Ethyl acetate ≤5000ppm Acetone ≤5000ppm DMF ≤880ppm Chloroform ≤60ppm

MP or BP: 161-162 °C(lit.) Appearance:white crystalline Application:A bronchodilator and coronary artery effect, and hae a diuretic effect.

Appearance White to almost white powder Identification Infrared absorption Solubility Practically insoluble in water, slightly soluble in methanol. It dissolves in dilute mineral acid. Appearance of solution Clear and colorless Specific optical rotation -30°~ -36° Water NMT 5.0% Sulphated ash NMT 0.1% Diethylamine NMT 0.5% Related substances Impurity D NMT 3.0% Impurity G NMT 1.0% Impurity J NMT 0.5% Impurity H NMT 0.5% Impurity B NMT 0.3% Impurity I NMT 0.2% Unspecified impurities NMT 0.1% Total of impurity NMT 5.5% Assay 94.0%~102.0%

Appearance Yellow crystalline powder Assay 99% min Loss on drying 5.0% max Residue on ignition 1.0% max

Appearance White crystalline powder, odorless Identification IR: Concordant with R.S HPLC: TR Concordant with R.S Specific rotation -49.0°~-55.0° Related substance 2.0% max Microbial limits Concordant with R.S Bacterial endotoxins Concordant with R.S Loss on drying 1.0% max Residue on ignition 0.2%max metals 20ppm max Assay(HPLC) 97.0-102.0

Description Crystalline powder,odorless Conforms Solubility Easily soluble in water, unsoluble in ethanol Conforms PH 6.0~7.5 6.9 Solution clarity and color solution should be clear and colorless Conforms Related substances 5’CMP 0.3% Simple impurity Total other impurity 0.01% 0.03% 0.10% Chloride 0.05% Conforms Ammonium 0.05% Conforms Fe 0.01% Conforms Phosphate 0.1% Conforms Loss on drying ≤6.0% 1.3% metals 0.002% Conforms Arsenide 0.0001% Conforms Bacterial Endotoxins 0.3EU/mg Conforms Microbial Limit Conforms Conforms Assay(on dried basis) ≥99.0% 99.8%

Appearance White powder Assay 99%min ash NMT0.1% Related substances NMT0.5% Loss on drying NMT 0.5% metals NMT 20 PPM