Appearance A white to off white powder Identification A. IR: Sample IR spectrum corresponds with that of the standard B. HPLC: The RT of the major peak of the Test solution corresponds to that of the Standard solution C: PXRD: Positive Loss on drying NMT 1.0% metals NMT 20ppm Sulphated ash NMT 0.1% Related substances α-Decitabine:≤0.15% Single unknown impuritie:≤0.1% Total impurities:≤1.0% Residual solvents DMSO:NMT 0.5% Methanol: NMT 0.3% Methyl formate: NMT 0.05% Acetonitrile: NMT 0.041% Methyl toluate: NMT 0.05% Assay(HPLC) 98.0-102.0%(On the dried basis)

Appearance White to off white powder Melting point 257 - 270℃ Specific optical rotation +137°~ +139° metal ≤20ppm Loss on drying ≤0.5% Solvent residue ≤0.5% Total impurity ≤1.0% Assay 99% min

Appearance White needle crystal Assay, HPLC 99%min Melting point 225-230℃ Solubility Soluble in DMSO, Slightly soluble in Ethanol Residue on Ignition 0.1% max Impurity A 0.5% max Impurity B 0.5% max Impurity C 0.15% max Impurity D 0.15% max metals 20ppm max Loss on drying 0.5% max

Appearance White Powder Assay 99% min. Solubility Water soluble Single impurity 0.2% max Loss on drying 0.5% max Storage Tightly closed, keep at Room Temp and dry

Appearance White or off-white powder Assay 86.3-100.7% Specific optical rotation +175~+190˚ Identification Should comply with USP35 PH 5.0-7.5 Water 1.0% max Related substance Piperacillin related compound A: 3.5% max Piperacillin related compound C:1.0% max Bacterial endotoxins 0.07 USP EU/mg of piperacillin max Sterility Should be sterile

Appearance A white or almost white crystalline powder Identification The infrared absorbance spectrum is concordant with the reference spectrum Acidity It should be yellow Melting point 136.0℃-142.0℃ Loss on dried 0.5% max Residue on ignition 0.1% max metal 20ppm max Phosphate 0.05% max Residual solvents Chloroform: 60ppm max Acetone: 5000ppm max Assay 98.5%-101.0%

Appearance Yellowish crystallization Solubility Soluble in ethanol, slightly soluble in aether, insoluble in water Residue on ignition 0.1% max Loss on drying 0.5% max Melting point 219~225℃ metals 15ppm max Chloride 0.01% max Assay( On dried basis) 99.0% min

Appearance White to off-white powder Indertification Conform Malting point 136-140℃ Assay by HPLC NLT99.0% Total impurity NMT 1.0% Individual impurity NMT0.20% Water content%(K&F) NMT0.5%

Appearance A white or almost white crystalline powder Identification The position of principal spot in the chromatogram abtaine with the test solution correspond to the standard. Specific optical rotation +75~+80˚ Loss on drying 0.5% max Residue on ignition 0.2% max Related substances Total impurities: 2.0% max Any individual impurities: 1.0%max Residual solvents Acetone: 5000ppm max Methanol:3000ppm max Tetrahydrofuran:720ppm max Pyridine: 200ppm max Assay,on dry base 97-103%

Appearance Yellow crystalline powder Identification According to USP37 Specific optical rotation -188˚ ~-200˚ Solubility Freely soluble in water sparingly soluble in ethanol,solutions in water become turbid on standing to the precipitation of Oxytetracycline. PH 2.3--2.9 PH Value 270--290 metals Not more than 50 Light absorbing impurities A(0.2%,1cm,430nm)

Appearance A white or almost white powder, hygroscopic Identification Very soluble in water, practically insoluble in ethanol A.TLC-test: principal spot should be as per ref. standard B. Reaction with ferric chloride: violet color develops C. Reaction with sodium hypochlorite: Red color develops D. Reaction with hydrochloric acid: faint yellow color develops E. Reaction of sulphate Appearance of solution Color: not more intense than ref. Sol. 3 Clarity: Not more opalescent than ref. suspension II PH 4.5-7.0 Methanol 0.3% max Streptomycin B 3.0% max Loss on drying 7.0% max Sulphated ash 1.0% max Sulphate 18.0%~21.5% Colorimetric test 90.0%min Assay(dried potency) 720 IU/mg min

Appearance Off white to white crystalline powder Solubility Freely soluble in chloroform, soluble in water and Acetic acid, slightly soluble in Acetonitrile and ethanol, insoluble in Ethylacetoacetate and n-hexane Identification (1)By IR absorption ,To match with working standard (2) The retention time of the major peak of the sample should accord with that of the working standard. (3) Test for chlorides. Reponds to the test for Chlorides. PH 4.0-7.0 Residue on ignition ≤0.1% Related substance Any Unkonwn single impurity≤0.3% Total ≤0.5% metal ≤10ppm Residual Solvents Methanol≤0.3% Ethanol≤0.5% Ethyl acetate≤0.5% Toluene≤0.089% Acetic acid≤0.5% Loss on drying ≤0.5% Assay On dried base, C24H29NO3•HCl should be 99.0% to 102.0%