Appearance Slight yellow oily liquid Identification IR,UV Assay 98%min Methanol 0.5% max Benzene 5.0% max

Appearance White or almost white crystalline powder Solution Clearing Identification Conform to standard Melting point 172~178℃ Specific rotation +34°~ +38°(C=2, in dioxane) Loss on drying 1.0% max in vacuum over P2O5 for 4h Organic volatile impurities ≤850ppm Assay 97.0~103.0%

Appearance White crystalline powder Identification IR,UL Specific rotation +34.0~+40.0°(C=1,Chloroform) Loss on drying ≤1.0%(5mm Hg,100℃) Residual solvents Ethanol: ≤5000ppm Organic volatile impurities Meets the requirements Total impurities 2.0% max Assay (on dried basis) 98.0~100.5%

Appearance White to light yellow crystalline powder Identification A B C Melting range 34.0~39.0℃ Specific rotation 77.0°~ 83.0° Free heptanoic acid ≤0.15% Water ≤0.05% Assay 97.0~103.0%

Appearance White or Almost White Crystalline Powder Assay 97.0~103.0% Identification Positive Specific Rotation +83°~ +90° Loss On Drying ≤0.5% Melting Point 118~123℃ metals ≤20 ppm

Appearance Off-white or white grey powder. Loss on drying ≤1.0% Melting point 121-123℃ Single impurity ≤0.1% Purity (HPLC) ≥99.0% Packing Two-layer plastic bag Storage Store in a well-closed place with constant low temperature and no direct sun light Shelf life 2 years when properly stored

Prasugrel 15942-05-9 普拉格雷 C20H20FNO3S 99% white or off-white crystalline powder

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)