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Product Name: Tiamulin Hydrogen Fumarate

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CAS No: 125-65-5

Melecular Formula: C22 H34O5

Molecular Weight: 378.5024


Chemical Structure:


Certificate of analysis

Product Name

Tiamulin Hydrogen Fumarate

Reference

USP36

Shelf Life

5 years

Character

White or almost white crystal powder.

White crystal powder


Identification

1.HPLC:The retention time obtained from the test solution corresponds to that obtained from the standard solution


Conforms


2.Infra-red spectrum:Infra-red spectrum of the sample corresponds to that of the reference standart.

Color and clarity of solution

The solution should be clear and colorless and the absorbance at 400nm and 650nnt is not greater than 0.150 and 0.030

Clear and colorless
     400nm 0.021
   650nm 0.003

Melting point

143~152℃

148℃

Compared to optical rotation


+24℃~+28℃


+26℃

pH

3.1~4.1

3.6

Loss on drying

Not more than 0.5%

0.25%

Burning residual

Leaves behind the residual to be supposed not to have 0.1%


0.05%

Heavy metal

Not more than 0.001%

Conforms

Solvent residue

Content of sovlvent residue is not more than 0.5%

0.12%


Chromatogrphic  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.

	

	Conforms

Content of fumarate

83.7~87.3mg

85.32 mg

Assay
     (As anhydrous)

Accrding to the anhydrous substance computation.
   Contains Tiamulin Fumarate to be supposed not less than 97.0% not more than 102.0%


98.26%

Conclusion: This conforms to the USP36.

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