Appearance Grey or beige powder with special odor Identification A:Spectrophotometry:the main absorption is found in 250mm—256mm.the max absorption is found at 269—275mm. B:TLC:Position and colour of chromatogarm of principle spots obtainrd from test preparation correspond to the standard preparation. Loss on drying ≤8.0% Granularity 100%pass the 2#sieve Container capacity The container capacity should not be less than the Labelled amount;yhe capacity for the every container should mot be less than 98.0% of thr labelled amount. Potentcy The assay of Enramycin should be in 90.0%-110.0% of the labelled amount.

Appearance White or almost white crystalline powder Melting range 79~82℃ Acidity Should be consistent with the standard Residue on ignition ＜0.1% Chloride ＜0.01% Sulfate ＜0.01% metals ＜20ppm Loss on drying ＜0.5% Solubility Practically insolubility in water Soluble in dichloromethane Slightly solubility in ethanol Related substance Impurity A＜0.1% Impurity B＜0.1% Impurity C＜0.2% Any other impurity＜0.1% Total impurity＜0.5% Residual solvents Acetone＜0.5% Isopropyl alcohol＜0.5% Toluene＜0.089% Chloroform＜0.006% Assay On anhydrous basis: 98.0%`102.0%

Characters A white or almst white powder hygroscopic,soluble in about 1 part of water practically insoluble in acetone and in alcohol. Identification A.Kanamycin by TLC B.Melting point(≈235℃) C.Kanamyycin by ninhydrin test D.Reaction of sulphate PH 5.5 TO 7.5(1% w/v) Specific optical rotation +103° to 105°(1% w/v) Kanamycin B ≤4.0% Sulphate 23.0% to 26.0% Loss on drying ≤5.0%(60℃, ≤0.7Kpa,3h) Sulphated ash ≤0.5% Assay(dried substance) ≥670 IU/mg Abnormal toxicity Approved Pyrogens Approved sterility Approved Residual solvents Ethanol≤500ppm

White lustrous crystalline powder, 99%min

Appearance A white or almost white powder Identification Complies with the infrared absorptions of RS Clarity and color of the solution Should be clear and colorless Loss on drying 1.0% max Residue on ignition 0.1% max metal 10ppm max Related substance Single impurity: 0.1% max Total impurity: 0.3% max Isopropanol 2000ppm max Methanol 1500ppm max Assay 98%-102%

Appearance Colourless or pale yellow, crystalline powder Identification IR absorption spectrum UV absorption spectrum Clarity and colour of solution 2.0% solution in 0.1M citric acid is clear. Sight than reference solution BY6. 5-Aminoimidazole-4-carbox amide hydrochloride 0.6% max Related Substances Any secondary peak 1.0% max The sum 3.0% max Loss on drying 0.5% max Sulphated ash 0.1% max Related compounds A: 1.0% max B: 1.0% max Volatils Organic Impurities Comply class 1,2&3 Bacterians Endotoxins Max 0,3 UE/mg Residual solvents Methanol : ≤3000ppm Assay 98.5~101.0%

Appearance White to slight yellow,crystalline powder Identification Complies Specific -75~~880 PH 2.6~~4.1 Water (K.F) 9.0~~12.0 Particle size distribution Informative Chromatographic purity Individual impurity ≤1.0 Total impurity ≤2.0 Residual solvent Acetone ≤0.5 Dichloromethane ≤600 Methanol ≤0.3 Assay (HPLC) 950~1030

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