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Appearance White crystalline powder Solubility Freely soluble in methanol, ethanol, ethylacetate and chloroform, slightly soluble in water and 0.1M hydrochloric acid solution Identification IR,HPLC Water 0.3% max Residue on ignition 0.1% max metals 0.001% max Related substances Related compound B: 0.2% max Related compound C: 0.2% max Related compound D: 0.1% max Related compound E: 0.1% max Individual unspecified impurity: 0.1% max Total unspecified impurity: 0.2% max Total impurities: 0.5% max Residual solvents Dichloromethane: 0.06% max Chloroform: 0.006% max Ethanol: 0.5% max Cyclohexane: 0.08% Ethylacetate: 0.5% max Assay(on dry basis) 98.0%~102.0%

"Appearance White or off white crystalline powder Solubility Freely soluble in pyridine and acetic acid(100), sparingly soluble in methanol, slightly soluble in ethanol, very slightly soluble in water, and practically insoluble in diethyl ether Melting point 159~163℃ Identification (a) positive reaction must comply (b) positive reaction must comply (c) UV There is the strongest absorption at the waelength of 234~238nm and 275~278nm (d) IR There is absorption at 1741,1703,1585,1241 and 706 cm-1 Relative substances E-isomer 0.5% max Total impurities 1.0% max metals 10ppm max Loss on drying 1.0% max Toluene 0.089% max Ethanol 0.5% max Acetone 0.5% max Tetrahydrofuran 0.072% max Chlorobenzene 0.036% max Benzene 0.0002% max Residue on ignition 0.1% max Assay 98.5% min "

Appearance White or almost white powder Identification (1),(2),(3) must complies with the EP 7.0 Melting point 200℃~ 204℃ Specific optical rotation +58.0°~ +62.0° Impurity A Not more than 1.0% Impurity C Not more than 0.1% Any other impurity B,D,E,F,G,H,I Not more than 0.1% The unknown impurity Not more than 0.1% Total impurity Not more than 1.5% Sulfate Not more than 0.05% Chloride Not more than 0.02% Sulfated ash Not more than 0.1% Loss on drying Not more than 1.0% metals Not more than 10ppm Purity(HPLC) Not less than 99.0% Assay ( on dried basis) 99.0% ～ 101.0%

Appearance Light yellow powder or crystalline powder Solubility Soluble in water, slightly soluble in Methanol, Ethanol. Hardly soluble in Chloroform. Soluble in 0.1mol/L HCl solution Rotation +90.0°~ +100.0° IR absorption Max at 223,267,312,328,381nm and Min at 250,287,318,338nm Chloridate Meet requirement PH 3.0~5.0 Color of the liquid Complies requirement Related substance A: Single impurity ≤0.5% B: All impurity ≤1.0% Water 12% max Dichloromethane ＜0.06% Ash ＜0.2% metals ＜20ppm Heat source Complies requirement Assay(HPLC) ＞98%

Appearance Pale yellow colored powder Identification (HPLC) The RT of the principle peak of sample should match with that of working standard PH 3.0-5.0 Total impurities NMT0.5% Water 7.0-9.0% Metals NMT 20ppm Specific rotation +60° to +73° Individual impurity NMT1.0% Purity NLT 99.0%

Appearance White crystalline powder, odorless Solubility Freely soluble in anhydrous ethanol, soluble in methylene chloride Practically soluble in water Identification HPLC The appearance time of docetaxel is concordant with the appearance time form docetaxel standard IR The spectrum of docetaxel is concordant with the spectrum of obtain from docetaxel standard Clarity of the solution Solution S is not more intensely colored than reference suspension Ⅱ Color the solution Less than the reference solution B5 Specific rotation -38.5~-41.5° Related substance Impurity A≤0.2% Impurity B≤0.3% Impurity C≤0.15% Impurity E≤0.15% Other single impurity≤0.5% Sum of impurities ≤1.0% Dichloromethane ≤0.06% N-hexane ≤0.029% Ethyl acetate ≤0.5% Acetone ≤0.5% Methanol ≤0.3% Water ≤1.5% Sulphated ash ≤0.1% metals ≤20ppm Bacterial endotoxins ＜0.3IU/mg Assay 97.5~102.0%

Appearance Light Yellow powder Identification IR-FT Complies HPLC Complies NMR Complies Mass Complies Residue on ignition ≤0.10% Related substances Total impurities ≤1.0% Single impurity ≤0.50% Loss on drying ≤1.00% Metal ≤10ppm Assay （HPLC） ≥99.0%

Appearance Off white light yellow solid Purity 98.0% min Loss on drying 0.5% max Residue On Ignition 0.2% max

Appearance White or almost white powder Identification H-NMR, MS Loss on Drying ?1.0% Related Impurity by HPLC Total impurity ≤1.5% Assay (HPLC) ?98.5%

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)