Josamycin is a macrolide antibiotic and an active pharmaceutical ingredient used for the treatment of susceptible bacterial infections. It belongs to the 16-membered macrolide antibiotic group and exhibits antibacterial activity primarily by inhibiting bacterial protein synthesis.
Josamycin is active against a range of Gram-positive and selected Gram-negative bacteria, as well as certain atypical respiratory pathogens. It is used in pharmaceutical formulations for appropriate bacterial infections where macrolide therapy is indicated.
Josamycin is a naturally derived macrolide antibiotic produced by Streptomyces narbonensis var. josamyceticus. It has the molecular formula C42H69NO15 and a molecular weight of 827.99 g/mol. The compound is characterized by a large 16-membered macrolide lactone ring containing amino sugar and neutral sugar components.
Josamycin is generally supplied as a white to off-white crystalline powder and is used as a pharmaceutical-grade active ingredient.
Josamycin inhibits bacterial protein synthesis by binding to the 50S subunit of the bacterial ribosome. This interferes with peptide-chain elongation and reduces bacterial protein production, resulting in inhibition of bacterial growth.
Josamycin is used for the treatment of susceptible bacterial infections, including selected respiratory tract, skin and soft-tissue, and other infections caused by susceptible organisms. Its use depends on bacterial susceptibility and applicable prescribing guidelines.
Josamycin API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, microbial quality where applicable, and elemental impurities. HPLC and suitable spectroscopic methods may be used for identity, assay and purity assessment.
Acceptance criteria should be based on the applicable pharmacopoeial monograph or approved manufacturer specification and Certificate of Analysis.
Josamycin should be stored in a tightly closed pharmaceutical-grade container under controlled storage conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer's specification.
Josamycin API may be supplied for qualified pharmaceutical manufacturing, formulation development, research and analytical applications. Product specifications, Certificate of Analysis, packaging details and regulatory documentation should be confirmed according to the intended application.
Josamycin API is available for pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory requirements. Customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details for their specific requirements.
| 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% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |