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(ITEMS )
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( STANDARDS )
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Appearance
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Light yellowish Crystalline powder
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Solubility
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Water
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Slightly soluble
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|
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Sparingly soluble
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Ethanol (96%)
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Very slightly soluble
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Identification -IR Spectrum
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Concordant with the spectrum of reference substance
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Absorbance
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≤0.20
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Related substances (%)
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Impurity C, D, E
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≤0.2%
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Impurity A, B
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≤0.1%
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Unspecified Impurities
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≤0.2%
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Total Impurity
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≤0.5%
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Heavy metal
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≤20ppm
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Loss on drying
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≤0.5%
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Sulphated ash
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≤0.10%
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Assay(on the dried basis):
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99.2%-99.5%
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Malbofloxacin is used for the infection of respiratory tracts, digestive tracts, urinary tracts and skin caused by sensitive bacteria in cattle, pigs, dogs and cats. It is also effective for cattle, sheep mastitis, and swine mastitis-myometitis-agalactia syndrome.
Function of Marbofloxacin
The pharmacokinetic behaviour of marbofloxacin, a new fluoroquinolone antimicrobial agent developed exclusively for veterinary use, was studied in mature horses (n = 5) after single-dose i.v. and i.m. administrations of 2 mg/kg bwt. Drug concentrations in plasma were determined by high performance liquid chromatography (HPLC) and data obtained were subjected to compartmental and noncompartmental kinetic analysis. This compound presents a relatively high volume of distribution (V(SS) = 1.17 +/- 0.18 l/kg), which suggests good tissue penetration, and a total body clearance (Cl) of 0.19 +/- 0.042 l/kgh, which is related to a long elimination half-life (t(1/2beta) = 4.74 +/- 0.8 h and 5.47 +/- 1.33 h i.v. and i.m. respectively). Marbofloxacin was rapidly absorbed after i.m. administration (MAT = 33.8 +/- 14.2 min) and presented high bioavailability (F = 87.9 +/- 6.0%). Pharmacokinetic parameters are not significantly different between both routes of administration (P>0.05). After marbofloxacin i.m. administration, no adverse reactions at the site of injection were observed. Serum CK activity levels 12 h after administration increased over 8-fold (range 3-15) compared with pre-injection levels, but this activity decreased to 3-fold during the 24 h follow-up period. Based on the value of surrogate markers to predict clinical success, Cmax/MIC ratio or AUC/MIC ratio, single daily marbofloxacin dose of 2 mg/kg bwt may not be effective in treating infections in horses caused by pathogens with an MIC > or = 0.25 microg/ml. However, if we use a classical antimicrobial efficacy criteria, marbofloxacin can reach a high plasma peak concentration and maintain concentrations higher than MICs determined for marbofloxacin against most gram-negative veterinary pathogens throughout the administration period. Taking into account the fact that fluoroquinolones are considered to have a concentration-dependent effect and a long postantibiotic effect against gram-negative bacteria, a dose of 2 mg/kg bwt every 24 h could be adequate for marbofloxacin in horses.
Dosage :
Intramuscular injection of 2mg per 1kg body weight of cattle and pigs once a day
Orally administered 2mg per LKG body weight of livestock once a day
[Preparation and Specification] Mbofloxacin tablets (1)5mg (2)20mg (3)80mg
Mbofloxacin injection lmL: 100mg
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