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%

Characters A white or almost white powder Identification A Conform Identification B Conform pH 6.0~8.0 metals 0.003% max Water 2.0% max Sulfated Ash 1.0% max Chromatographic purity 1.0 % max Bacterial Endotoxins ≤2.0EU/mg Sterility Conform Potency (dried substance) 634ug/mg~739ug/mg Residual solvents Ethanol≤5000ppm

Appearance White or almost white crystalline powder Melting point About 96℃ Identification IR and UV Spectrum Solubility Practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. Appearance of solution Clear and cololess Related substances Impurity F: 0.5% max Impurity B: 0.2% max Impurity A.D.E.G.H: 0.1% max Any other impurity: 0.1% max Total impurities: 0.7% max Residual Solvents Ethanol: 5000ppm max Butyl Acetate: 5000ppm max Toluene: 890ppm max Loss on drying 0.5% max Sulphated ash 0.1% max metals 20ppm max Assay, on dry basise 98.0-102.0%

Appearance Yellow or pale yellow amorphous powder Identification By HPLC, IR and UV Conforms Assay(on the dried basis) ≥93.0% Related substance Anhydro-daptomycin≤3.5% β-isomer≤2.0% Lactone hydrolysis product≤1.5% Impurity RS-2 ≤0.5% Any other impurity≤0.15% Total impurities≤8.0% PH 3.0~5.0 Residue on ignition ≤4.0% Specific Rotation +17.0°~ +25.0° Residual organic solvents(GC) Ethanol≤0.5% Isopropanol≤0.5% metals ≤20ppm Water ≤10.0% Bacterial Endotoxin

Appearance A white or almost white crystalline powder Identification The infrared absorbance spectrum is concordant with the reference spectrum Appearance of solution The solutioiin are not more opalescent than ref. Suspension II PH 3.5-5.5 Specific rotation +290°~ +315° Related substances 1.0% max N.N-Dimethylaniline 20ppm max Water 11.5-14.5% Sulphated ash 1.0% max Assay, on dry base 95%-102% Conclusion Complies with standard of BP2012.

Appearance White or almost white crystalline powder Identification Should meet the requirement Specific optical rotation +270˚ -- +300˚ PH 5.5--7.5 Loss on drying 1.0% max Absorbance 264nm 280nm 325nm 0.8-0.88 Not more than 0.1 Not more than 0.1 Related substances Not more than 1.0% Sterility Should meet the qequirements Bacterial Endotoxins 0.16IU/mg max Assay(by dried substance) 98.0--102.0% of C16H18KN2O4S Potency ---

Characters: White crystalline or white crystalline powder, smell-less or slightly smell-less. Practically soluble in water, insoluble in chloroform, alcohol and olefin liquor. Identification: 1) The infrared collection of illustrative plates of sample is contract with the compared product. 2) The color of the sample is similar with that of kainite reaction. Specific optical rotation: +215°～+230° PH Value: 5.5～7.5 Absorbance 306nm: ≤0.33 274nm: ≥0.5 Phenoxyacetic Acid: ≤0.5% Related Substance: Meet the requirement 4-Hydroxyphenoxymethylpenicillin potassium: ≤4.0% Water: ≤0.8% The quantity of mildew and barm: ≤100 entries/g The color of the liquor≤2 Macromolecule impurity≤0.1% Eyewinker ≤6 entries/g 14 Stability Stability: stable under the requirement of storage. Decomposition Products: When heated to decomposition material emits toxic fumes of NOx, K2O and SOx. Emits toxic fumes under fire conditions. 15 Toxicological Information The neuritis may happen in the penicillin skin injecting area. But this situation is infrequent. And must make test before injecting. The concentration of the medicine is 500 unit/ml.