Description White or off-white crystalline powder Solubility Very soluble in DMSO or ethanol, up to about 200 mg/mL; poorly soluble in aqueous solution Identification by NMR THE NMR spectrum of the sample should be the same as that of reference material Burned ash NMT 0.1% Metal NMT 20ppm Related substances Total impurities: NMT 1.0% Impurity A: NMT 0.3% Impurity B: NMT 0.3% Impurity C: NMT 0.3% other impurity: NMT0.1% Residual solvents Ethylacetate NMT 10000 PPM Dichloromethane NMT 2500 PPM Hexane NMT 600 PPM Purity NLT 99.0% Keep at – 20 ℃ for long term storage.

Appearance White to off-white,crystalline,nonhygroscopic solid Identification Infrared absorption spectrophotometry should correspond to that of cefepime hydrochloride CRS Clarity of solution Should be clear (the solution is less clear than an equal volume of water contained in a similar vessel and examined similarly) Particulate contamination No visible foreign matter Crystallinity Should complies Water 3.0~~4.5% Residue on ignition ≤0.1% metals ≤0.002% Residual solvents Methanol ≤ 0.3% Acetone ≤0.5% N-methypyrrolidine ≤ 0.3% Related compounds Cefepime related compound A≤0.3% Cefepime related compound B≤0.2% Any other impurity ≤0.1% Particulate matter ≥10 um ≤6000 Grain/g ≥25 um ≤600 Grain/g Bacterial endotoxins Not more than 0.04EU per mg of cefepime HCl Sterility Should be sterile Assay not less than 82.5%and not more than 99.1%(w/w) of Cefepime on the anhydrous basis

Appearance white or almost white powder Solubility Very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone Identification A:IR the infrared absorption spectrum exhibits maximum only at the same as that of the standard sample B: It gives reaction of chlorides Related substances Impurity B 0.15% max Impurity E 0.05% max Any other impurity 0.1% max Total of impurity 0.3% max Loss on drying 0.5% max Sulphated ash 0.1% max Residual solvents Isopropyl alcohol 5000ppm max Ethyl acetate 5000ppm max Chloroform 60ppm Assay 99.0~101.0%(dried substance)

Appearance Almost white or pale yellow crystalline powder Identification IR: Conforms to standard USP HPLC: Comforms to standard Assay,HPLC, on dry base C17H18FN3O3 98.0-102.0% Impurities Ciprofloxacin ethylenediamine analog:0.2% max Any other single impurity:0.2% max Total impurities: 0.5% max Clarity of solution Clear to slightly opalescent (0.25g/10ml 0.1N Hydrochloric acid) Loss on drying 1.0% max Residue on ignition 0.1% max Chloride 0.02% max Sulfate 0.04% max metals 20ppm max Fluoroquinolonic acid 0.2% max

Appearance white or almost white crystalline powder Identification Complies Water ≤5.0% Lead ≤0.001% metals ≤0.002% Saponification value(anhydrous basis) 142.2-146.0 Sodium stearyl maleate ≤0.25% Stearyl alcohol ≤0.5% Single impurity ≤0.5% Total impurity ≤5.0% Assay 99.0%-101.5%

Appearance Off-white to white powder IDENTIFICATIONS A, B, C conforms Standard USP35/NF30 PH 5.0-7.0 LOSS ON DRYING NMT 10.0% SODIUM GLYCOLATE CONTENT AND SODIUM CHLORIDE CONTENT NMT 0.5% WATER SOLUBLE MATERIAL NMT 10.0% SETTLING VOLUME 10ml-30ml DEGREE OF SUBSTITUTION 0.60-0.85 RESIDUE ON IGNITION 14.0%-28.0% METALS NMT 10ppm ORGANIC VOLATILE Absent MICROBIAL ENUMERATION TESTS Total aerobic microbial count

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