Address:
Shandong,China
Main Products:
feed additive,veterinary medcine,biological preparation,transfer factor,vaccine
SINDER GROUP CO., LTD.
ROOM D338, NO. 268 HONG KONG EAST ROAD,QINGDAO, CHINA
TEL: 8653288899823 FAX: 8653288895980
Certificate of Analysis
Tiamulin Hydrogen Fumarate | Batch No. | TMF0911149 |
Batch Size | 1000KGS | |
Mfg. Date | 2009129 | |
Exp. Date | Oct, 2014 |
Items |
SPECIFICATION |
RESULT |
Appearance | White or almost white crystal powder | Complies |
Loss on drying | ≤0.5% | 0.3% |
Melting Point | 143-149 | 147 |
Specific Rotation | +24-+28 | +27 |
Identification A | HPLC: The retention time obtained from the test solution corresponds to that obtained from the standard solution | Complies |
Identification B | Infra-red spectrum: Infra-red spectrum of the sample corresponds to that of the reference standard | Complies |
Color and clarity of solution | The solution should be clear and colorless, and the absorbance at 400nm and 650nm is not greater than 0.150 and 0.030 | Clear and colorless 400nm 0.023 650nm 0.003 |
PH | 3.1-4.1 | 3.7 |
Content of fumarate | 83.7-87.3mg | 85.8mg |
Residue on ignition | Not more than 0.1% | 0.01% |
Heavy Metals | Not more than 0.001% | Complies |
Solvent Residue | Content of solvent residue is not more than 0.5% | <0.3% |
Chromatographic Purity | Not more than 1.0% of any identified impurity is found, not more than 0.5% of any unidentified impurity is found, and not more than Complies 2.0% of total impurity is found | Complies |
Assay on dried basis | 98.0%-102.0% | 98.9% |
Conclusion: Complies with USP
Analyst: Chujunling | Collator: Zhangxiaohua | QC Director: Changhonglei |
FINAL BATCH DISPOSITION: Approved