Appearance White powder Identification Positive Loss on drying ≤5.0% Assay ≥98%

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