Kanamycin Sulfate is the sulfate salt of kanamycin, an aminoglycoside antibiotic used as an active pharmaceutical ingredient in antibacterial formulations. It acts primarily by inhibiting bacterial protein synthesis through binding to the 30S subunit of susceptible bacterial ribosomes.
Kanamycin Sulfate has activity against a variety of susceptible Gram-negative bacteria and selected Gram-positive organisms. It has also been used in specific treatment regimens for tuberculosis and other serious bacterial infections where susceptibility to kanamycin has been established and its use is appropriate under current treatment guidelines.
Kanamycin Sulfate is a highly polar aminoglycoside antibiotic supplied as a sulfate salt. It has the molecular formula C18H36N4O11·H2SO4 and a molecular weight of approximately 582.58 g/mol. The CAS Number is 25389-94-0.
Kanamycin Sulfate is generally supplied as a white to off-white powder and is freely soluble in water.
Kanamycin Sulfate binds to the 30S bacterial ribosomal subunit, interfering with the initiation and accuracy of bacterial protein synthesis. This results in misreading of messenger RNA and production of abnormal proteins, ultimately inhibiting bacterial growth and producing bactericidal activity against susceptible organisms.
Kanamycin Sulfate is used in pharmaceutical formulations for susceptible bacterial infections. It has historically been used for selected serious Gram-negative infections and as an aminoglycoside in certain tuberculosis treatment regimens. Its clinical use should follow current antimicrobial susceptibility data and applicable treatment guidelines.
Kanamycin Sulfate API can be evaluated using applicable pharmacopoeial and validated analytical procedures for identification, potency/assay, related substances, water content, sulfate content and elemental impurities. Suitable chromatographic and spectroscopic methods may be used for identification and quality assessment.
Acceptance criteria should be based on the applicable pharmacopoeial monograph or approved manufacturer's drug-substance specification and Certificate of Analysis.
Kanamycin Sulfate 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 approved specification.
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 Sulfate 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% |