Erythromycin Ethylsuccinate is a semisynthetic macrolide antibiotic and an ester derivative of erythromycin. It is used in pharmaceutical formulations to provide antibacterial activity against susceptible Gram-positive and selected Gram-negative bacteria.
Erythromycin Ethylsuccinate acts primarily by binding to the 50S subunit of bacterial ribosomes, inhibiting bacterial protein synthesis and thereby suppressing the growth of susceptible microorganisms.
Erythromycin Ethylsuccinate is the 2'-(ethylsuccinate) ester of erythromycin, developed to provide a suitable oral pharmaceutical form of erythromycin. It is commonly used in oral antibiotic formulations.
The molecular formula of Erythromycin Ethylsuccinate is C₄₃H₇₅NO₁₆, with a molecular weight of approximately 862.06 g/mol. The CAS Registry Number is 1264-62-6.
Erythromycin Ethylsuccinate exerts antibacterial activity by binding to the 50S ribosomal subunit of susceptible bacteria.
This interferes with:
The resulting effect is generally bacteriostatic, although bactericidal activity can occur against certain susceptible organisms at sufficiently high concentrations.
Erythromycin Ethylsuccinate is used in pharmaceutical formulations for susceptible bacterial infections, including certain:
The exact approved indications depend on the applicable product label and regulatory jurisdiction.
Erythromycin Ethylsuccinate is a macrolide antibiotic pharmaceutical ingredient. It is supplied for pharmaceutical manufacturing and formulation applications where the ethylsuccinate ester form of erythromycin is required.
Quality control generally includes identity, assay, related substances, water content, residual solvents and other applicable physicochemical parameters.
Pharmaceutical-grade Erythromycin Ethylsuccinate should comply with the applicable approved specification and relevant pharmacopoeial requirements.
Typical quality-control parameters include:
A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.
Erythromycin Ethylsuccinate should be stored in a tightly closed container, protected from excessive heat and moisture, under the storage conditions specified in the applicable approved specification and stability data.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |