Loracarbef is a synthetic oral β-lactam antibiotic belonging to the carbacephem class of antibacterial agents. It is structurally related to the cephalosporins but contains a carbon atom in place of the sulfur atom found in the dihydrothiazine ring of cephalosporins.
Loracarbef is a second-generation carbacephem antibiotic developed for the treatment of susceptible bacterial infections. It exerts its antibacterial effect by interfering with bacterial cell-wall synthesis.
Loracarbef is a synthetic small-molecule antibacterial compound with the molecular formula C16H16ClN3O4 and a molecular weight of approximately 349.77 g/mol. Its CAS Number is Loracarbef: 121973-18-6.
Loracarbef contains a β-lactam ring and is chemically related to the cephalosporin family. Its carbacephem structure provides antibacterial activity against a range of susceptible Gram-positive and Gram-negative organisms.
Loracarbef acts by binding to penicillin-binding proteins (PBPs) located within bacterial cell membranes.
This inhibits the final stages of peptidoglycan synthesis, an essential component of the bacterial cell wall. Disruption of cell-wall formation ultimately causes bacterial cell lysis and death.
Its antibacterial activity is therefore bactericidal against susceptible organisms.
Loracarbef has been used for the treatment of susceptible bacterial infections, including infections of the respiratory tract, skin and skin structures, urinary tract and other susceptible infections.
Its clinical use depends on the susceptibility of the causative organism and applicable regulatory approvals.
Loracarbef API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. Appropriate controls should be established for β-lactam-related degradation products and process-related impurities.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Loracarbef should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
Because β-lactam compounds can be susceptible to degradation under unsuitable environmental conditions, appropriate storage and handling controls should be maintained.
Loracarbef API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Loracarbef API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 2.0% |