NAME OF ITEM: TIAMULIN HYDROGEN FUMARATE 98%

ITEMS

SPECIFICATION (USP33)

RESULT

DESCRIPTION

WHITE OR ALMOST WHITE CRYSTAL POWDER

COMPLIES

LOSS ON DRYING

NOT MORE THAN 0.5%

0.4%

MELTING TEMPERATURE

143°C~149°C

143°C

SPECIFIC ROTATION

24°~28°

+27°

IDENTIFICATION

HPLC:THE RETENTION TIME OBTAINED FROM THE TEST SOLUTION CORRESPONDS TO THAT OBTAINED FROM THE STANDARD SOLUTION

INFRA-RED SPECTRUM:INFRA-RED SPECTRUM OF THE SAMPLE CORRESPONDING TO THAT OF THE REFERENCE STANDARD

COMPLIES

COLOR AND CLARITY

OF SOLUTION

THE SOLUTION SHOULD BE BLEAR AND COLORLESS,

AND THE ABSORBANCE AT 400nm AND 650nm

IS NOT GREATER THAN 0.150 AND 0.030

CLEAR AND COLORLESS

400nm 0.024

650nm 0.002

PH

3.1~4.1

3.7

SOLVENT RESIDUE

CONTENT OF ETHYL ACETATE NOT MORE THAN 0.5%

0.1%

RESIDUE ON IGNITION

NOT MORE THAN 0.1%

0.02%

HEAVY METALS

NOT MORE THAN 0.001%

COMPLIES

ASSAY(CALCULATED ON

THE DRIED BASIS)

98.0~102.0%

99.0%

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

CONTENT OF FUMARATE

83.7mg~87.3mg

84.9mg