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Specifications

Tiamulin Hydrogen Fumarate Soluble Powder
Use for stress reaction, cough before or after injection of vaccine, able to cure various of acute or chronical respiratory tract disease.
Mix with water: 100g with 180-200KG water, double dosage if  there is no antibiotics such as salinomycin, ryemycin, monensin used in feed
 
CERTIFICATE OF ANALYSIS 
Name of Product
Specification 
 
Tiamulin Hydrogen Fumarate
Batch No.
TMF0810318
Date of Expiry         
NOV. 05, 2011
MFG Date
NOV. ,06 2008
 
Analysis gist: USP 30
 
ITEMS
STANDARD
RESULT
Description
White or almost white crystal powder
Complies
Loss on drying
Not more that 0.5%
0.4%
Melting temperature
143℃-149℃
145℃
Specific Rotation
24℃-28℃
+25℃
Identification
HPLC:The retention time obtained from the thest
Solution corresponds to that Obtained from the standard solution
Complies
Color and clarity of solution
The solution obtained from with the method of USP 28: clear and colorless, and the absorbance at 400nm and 650nm is not greater than 0.150 and 0.030
Clear and colorless      400nm 0.020     650nm 0.005
PH
3.1-4.1
3.6
Content of fumarate
93.7mg-87.3mg
84.2mg
Residue on ignition
Not more than 0.1%
0.07%
Heavy metals
Not more than 0.001% 
 Complies
Solvent residue
Content of Ethyl Acetate not more than 0.5% 
<0.4% 
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 2.0% of total impurities is found 
Complies 
Assay (Calculated on the dried basis)
    98.0-102.0%
98.9%
CONCLUSION
 Qualified
If you have any question about the result, please apply recheck in 15 days.