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Dirithromycin

Dirithromycin

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Packaging Details: 25 kilos/drum
Delivery Detail: Within 7days after confirm the order

Specifications:
Product name: Dirithromycin / CAS: 62013-04-1
Dirithromycin is a macrolide glycopeptide antibiotic. Dirithromycin is a more lipid-soluble prodrug derivative of 9S-erythromycyclamine prepared by condensation of the latter with 2-acetaldehyde. The 9N, 11O-oxazine ring thus formed is a hemi-aminal that is unstable under both acidic and alkaline aqueous conditions and undergoes spontaneous hydrolysis to form erythromycyclamine. Erythromycyclamine is a semisynthetic derivative of erythromycin in which the 9-ketogroup of the erythronolide ring has been converted to an amino group. Erythromycyclamine retains the antibacterial properties of erythromycin oral administration. The prodrug, dirithromycin, is provided as enteric coated tablets to protect it from acid catalyzed hydrolysis in the stomach. Orally administered dirithromycin is absorbed rapidly into the plasma, largely from the small intestine.

Items Specifications
Characteristics
A white or almost white, crystalline powder
Soluble in water
Identification The retention time of major peak in the chromatogram of the sample corresponds to the standard

IR
Dirithromycin 15S-epimer%
≤1.5
Heavy metals
≤20ppm
Water%
≤1.0
Sulphated ash%
≤0.1
Impurities%
9-(S)-erythromycylamine ≤1.5

Other single impurity ≤1.0

Total impurities ≤4.0
Assay%
96.0~102.0
Particle size
100% through 60 or 80 mesh sieve
Residual solvent
Acetonitrile≤0.1%
Ethyl ether≤5000ppm
Dichloromethane≤600ppm
Methanol≤3000ppm
2-propanol≤5000ppm
Usage
Dirithromycin is a macrolide antibiotic pro-drug of 9S-erythromycylamine, a close analogue of erythromycin in which the 9-keto group is replaced with an amino group in the S-configuration. Although erythromycylamine overcomes the acid instability of erythromycin, it is poorly absorbed following oral administration. Dirithromycin is formed by reacting erythromycylamine with an aldehyde to form a Schiff base which undergoes cyclisation to an oxazine with the C11-alcohol. Dirithromycin provides higher tissue levels and prolonged in vivo half-life by slowly releasing erythromycylamine.
Usage
Semi-synthetic derivative of Erythromycin. Antibacterial

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