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)

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%