Appearance White to yellowish-white powder Very soluble in ethanol or chloroform; soluble in water and practically insoluble in ethyl ether Identification (1) IR (2) HPLC Water 5.0% max Residue on ignition 0.2% max metals 20ppm max Methyl benzenesulfonate 0.01% max Toluene 890ppm(ICH) max Chromatographic purity (1) Laudanosine: 0.5% max (2) Any other individual impurity 1.0% max (3) Total impurities 3.5% max Isomer ratio (1) trans-trans isomer 5.0%~6.5% (2) cis-trans isomer 34.5%~38.5% (3) cis-cis isomer 55.0%~60.0% Assay 96.0%~102.0% Residual solvents (1) Dichloromethane 600ppm max (2) Acetonitrile 410ppm max

Appearance White or off-white Crystalline powder Identification 1. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chtomatogram of the Standard preparation,as obtained in the Assay. 2. It responds to the tests for Sodium Crystallinity Meets the requirements Water 5.0%max PH 4.5-6.5 Assay 870 ug/mg min (calculated on the dried basis)

Appearance Yellow crystalline powder Identification A: Thin-layer chromatography B: Reaction in silver nitrate solution C: Developing colour reaction PH 3.5~6.0 Specific optical rotation -260°~ -280° Loss on drying ≤13.0% metals ≤50ppm Sulphated ash ≤0.5% Related substances 4-Epi tetracycline ≤5.0% 4-Epi anhydro tetracycline ≤0.5% Anhydro tetracycline ≤1.0% 2-Acetyl-2-decarbamoyl tetracycline ≤2.0% Assay 88.0~102.0% Microbiological examination TAMC ≤1000cfu/g TYMC ≤100cfu/g E.coli Absence

Appearance White or off-white Crystalline powder Identification Complies Pyridine 0.4% max Sodium Carbonate Informative PH 5.0-7.5 Loss on drying 13.5% max HIAC test Particies ≥10μm 3000 max Particies ≥25μm 300 max Residual solvents Ethanol 0.5% max Acetone 0.5% max Bacterial endotoxins 0.1 Eu/mg max Sterillty Sterile Assay，as ceftazidime form 90.0~105.0% Constituted solution Complies

Appearance White to light yellow crystalline powder PH 5.5~7.5 Loss on drying ≤3.0% Related substances 2,3-Cyclopenteno pyridine≤1.0% Total impurities:≤3.0% Cefpirome polymer ≤0.5% Bacterial endotoxins ≤0.10EU/mg Visible particles It meets the requirement Particulate matter It meets the requirement Particular matter ≥10um ≤6000/g ≥25um ≤600/g Specific volume Report the result Sterility It meets the requirement Assay Not less than 65% of Cefpirome, calculated on the anhyfrous

Description White or almost white crystalline powder Identification Conform Acidity(PH) 5.5-7.5 Specific Optical Rotation +285^-+310^ Absorbance: 264nm 0.80~0.88 280nm ≤0.10 325nm ≤0.10 Related Substance ≤1% 2-Ethylhexanoic Acid ≤0.5% Loss on Drying ≤1.0% Sterility Conform Bacterial Endotoxins ＜0.16IU/mg Assay(As dry substances) 96.0%-102.0% Potency(As dry substances) --

Appearance White powder Assay 97.0-103.0% Water ≤0.5% Identification POSITIVE Residue on ignition ≤0.30% Oraganic volatile impurities ≤0.03% Particle Size 90%＜12um 10%btn 12～25um

Appearance White or almost white crystalline powder Identification (1),(2),(3) Appearance of solution 5# max Clear 1# max PH 8.0-10.0 Specific optical rotation +258˚ ~+287˚ Residual Solvents Comply with standard Related substance Comply with standard 2-ethylhexanoate 0.8% max Water 2.0% max Bacterial endotoxins 0.1IU/mg max Sterility Confirm Assay(on dry base) 85% min

Appearance White or almost white crystalline powder Identification (IR,HPLC) Complies with the Standard Specific optical Rotation +79.0°～+86.0° Related Substances Single impurity ≤0.5% Total impurities ≤2.0% Loss on drying ≤0.5% Assay(UV, basis on drying) 97.0~103.0%

Identification 1.A deep blue color is produced. 2.positive reaction Loss on drying Not more than 8.0% Residue on ignition Not more than 0.025% Iodine ion Not more than 6.6% metals Not more than 0.002% Nitrogen Not less than 9.5% and not more than 11.5%（ON the dried basis) Assay Povidone-Iodine contains not less than 9.0 percent and not more than 12.0 percent of iodine(I),calculated on the dried basis.

The appearance of the product A white to yellowish white powder PH（5% in water） 3.0~7.0 Water ≤5.0% Sulfated Ash ≤0.1% Metals（as Lead） ≤10PPM Acetaldehyde ≤0.05% Hydrazine ≤1PP N-Vinylpynrrolidinone ≤10PPM K-value 27-32 Nitrogen content 11.5~12.8% H2O2 ≤400PPM

Appearance White or almost white crystalline powder Assay 97-103% Melting point 155~161℃ Identification Infrared absorption absorption Specific rotation +171°~ +179° Loss on drying 0.5% max Related substances Total impurity: 2.0% max Individual impurity: 0.5% max