Appearance White or almost white crystalline powder Identification A: IR absorption B: UV absorption C: TLC Melting point 168~172℃ Water 0.5% max Related substances Impurity J(chloroacetanilide) 10ppm max Impurity K(4-aminophenol) 50ppm max Impurity F(4-nitrophenol) 0.05% max Any other impurities 0.05% max Total of impurities 0.1% max Residue on ignition 0.1% max Chloride 0.014% max Sulfate 0.02% max Sulfide Conforms metals 0.001% max Free p-aminophenol 0.005% max Limit of P-chloroacetanilide 0.001% max Readily carbonizable substances Conforms Residual solvents Residue content of acetic acid is limited by the test of loss on drying not more than 0.5% Assay(anhydrous basis) 99.0~101.0%

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)

Appearance A white or almost white crystalline powder Solubility Practically insoluble in water,freely soluble in methylene chloride,soluble in acetone, slightly soluble in methanol,dehydrated alcohol and in acetonitrile.Slightly soluble in phosphate buffer at PH values of 2-5. Identification IR Conforms to Clarithromycin RS Crystallinity Meets the requirements Specific optical rotation -94°~-102° PH 8.0-10.0 Water 2.0% max Sulphated ash 0.2% max metals 20ppm max Related substances I,A,J,L,B,M,C,D,N,E,F,P,O,K,G,H:1.0%Max Any other impurity:0.1% max More than 0.4% impurity: 4 max Total impurities:3.5% max Assay(on dry base) 96.0%~102.0% Residual solvents Ethanol 3000ppm max Bulk density 0.30g/ml~0.55g/ml Tapped density 0.55g/ml~0.80g/ml Particle size 90%min passes through 40mesh

Appearance White or off-white powder Assay,dried base 99.0%min Odor&Taste No special odor Solubility Soluble in chloroform and ethanol, insoluble in water Flash point 326-327 Total impurity 2.0% max Individual impurity 0.5% max Loss on drying 0.5% max Residue on ignition 0.1% max metals 20ppm max Microbiology Total Plate count: 1000cfu/g max Yeast&Mold: 100cfu/g max E.Coli: Negative S.Aureus: Negative Salmonella: Negative

Sirolimus 53123-88-9 雷帕霉素 C51H79NO13 99%min 无味,白色至类白色结晶粉末

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