Tiamulin fumarate is a semi-synthetic derivative of Pleuromutilin. It is highly active against gram-positive organisms such as streptococci, staphylococci and against mycoplasmas and serpulina (Treponema) hyodysenteriae. A number of Shigella, Klebsiella and E. coli are also quite susceptible to this agent. Some anaerobic species including Bacteroides fragilis and Clostridium perfringens with no exception are sensitive to tiamulin. Tiamulin acts bacteriostatically.
AppearanceWhite or almost white crystal powderComplies
IdentificationHPLC: The retention time obtained from the test solution corresponding to thatobtained from the standard solution0.2%
IR: IR of the sample corresponding to that reference standardComplies
Color and clarity of solutionThe solution should be clear and colorless, and the absorbance at 400nm and 650nm are not greater than 0.150 and 0.03099.8%
Specific rotation+24~28掳Complies
Loss on drying鈮?0.5%Complies
Melting point143~149掳C0.05ppm
Fumarate content83.7~87.3mg0.05ppm
Residue on ignition鈮?0.1%0.05ppm
Heavy metals鈮?0.001%Complies
Solvent residue鈮?0.5%Complies
Chromatographic purityAny identified impurity 鈮?1.0%
Any unidentified impurity 鈮?0.5%Complies
Total impurities鈮?2.0%Complies
Assay (on dried basis)98.0~102.0%Complies
SalmonellaNegativeCompliesVeterinary API factory

  • Created: 03-11-20
  • Last Login: 03-11-20

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