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Veterinary API factory

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14-12-20 0 Просмотров

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. ItemSpecificationResult AppearanceWhite or almost white crystal powderComplies IdentificationHPLC: The retention time obtained from the test solution corresponding to thatobtained from the standard solution0.2% 0.06% 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 PH3.1~4.10.12%~0.09% 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 website:http://www.arshinepharma.com/active-pharmaceutical-ingredient-api/veterinary-api/

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