Kanamycin is an aminoglycoside antibiotic and an active pharmaceutical ingredient used against susceptible bacterial infections. It is a naturally derived antibiotic produced by species of Streptomyces kanamyceticus and acts primarily by interfering with bacterial protein synthesis.
Kanamycin is active against a range of Gram-negative bacteria and selected Gram-positive organisms. It has also been used in specific tuberculosis treatment regimens and other serious bacterial infections where the causative organism is susceptible and aminoglycoside therapy is appropriate.
Kanamycin is an aminoglycoside containing amino sugars and an aminocyclitol ring. Kanamycin base has the molecular formula C18H36N4O11 and a molecular weight of 484.50 g/mol. The commonly used pharmaceutical salt, Kanamycin Sulfate, has the CAS Number 25389-94-0.
Kanamycin is highly polar and water soluble in its sulfate salt form. Pharmaceutical Kanamycin Sulfate is generally supplied as a white to off-white powder.
Kanamycin binds primarily to the 30S subunit of bacterial ribosomes. It interferes with the initiation and accuracy of protein synthesis, resulting in production of abnormal proteins and inhibition of bacterial growth. At sufficiently high concentrations, aminoglycosides can produce bactericidal activity.
Kanamycin and Kanamycin Sulfate are used in pharmaceutical formulations for susceptible bacterial infections. Kanamycin Sulfate has also been used as an aminoglycoside component in selected tuberculosis treatment regimens, subject to current treatment guidelines and antimicrobial susceptibility.
Kanamycin API and Kanamycin Sulfate can be evaluated using applicable pharmacopoeial and validated analytical procedures for identification, potency/assay, related substances, water content, sulfate content where applicable, residual solvents and elemental impurities.
Acceptance criteria should be based on the applicable pharmacopoeial monograph or approved manufacturer specification and Certificate of Analysis.
Kanamycin and Kanamycin Sulfate should be stored in tightly closed pharmaceutical-grade containers 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 specification.
Kanamycin and Kanamycin Sulfate 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.
Kanamycin API and Kanamycin Sulfate are 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% |