Gentamicin Sulfate is an aminoglycoside antibacterial API used against a broad range of susceptible Gram-negative bacteria and selected Gram-positive organisms. It is a sulfate salt mixture of the closely related gentamicin components, primarily gentamicin C1, C1a, and C2.
Gentamicin produces its antibacterial effect by binding to the bacterial 30S ribosomal subunit, interfering with protein synthesis and causing bacterial cell death.
Gentamicin Sulfate is an important pharmaceutical antibiotic ingredient used in the manufacture of injectable, ophthalmic, topical and other pharmaceutical preparations. As a fermentation-derived aminoglycoside, its manufacturing and quality control require characterization of component composition, potency and microbiological quality.
CAS Number: 1405-41-0
Molecular Formula: C21H43N5O7 · H2SO4
Molecular Weight: 575.67 g/mol
Drug Class: Aminoglycoside Antibiotic
Therapeutic Class: Antibacterial
Therapeutic Area: Infectious Diseases
Important: Gentamicin Sulfate is a mixture of related gentamicin components, so the molecular formula and molecular weight can vary depending on the component composition and representation of the salt. CAS 1405-41-0 is the standard CAS identifier for Gentamicin Sulfate.
Gentamicin binds primarily to the 30S subunit of bacterial ribosomes. This interferes with initiation and accuracy of bacterial protein synthesis, resulting in production of abnormal proteins and ultimately bacterial cell death. Its activity is concentration-dependent and requires susceptible organisms.
Gentamicin Sulfate is used in pharmaceutical preparations for susceptible bacterial infections. Depending on the formulation, applications include serious systemic infections, ophthalmic infections and certain topical bacterial infections.
It is commonly formulated for parenteral administration, while ophthalmic and topical formulations may be used for localized infections.
Gentamicin has significant activity against many aerobic Gram-negative bacteria and can be used in combination with other antibacterial agents against selected Gram-positive infections. Its clinical usefulness depends on the susceptibility of the organism and the applicable treatment guidelines.
Gentamicin Sulfate is a white to off-white powder and is highly polar because of its multiple amino and hydroxyl groups. It is readily soluble in water and is generally supplied as a sulfate salt containing several related gentamicin components.
Gentamicin Sulfate API quality evaluation may include:
Gentamicin Sulfate should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage requirements should follow the applicable validated stability data and product-specific specification.
Gentamicin Sulfate remains an important aminoglycoside antibacterial ingredient in pharmaceutical development. Its established mechanism of 30S ribosomal inhibition makes it relevant to antibacterial research, formulation development and antimicrobial susceptibility studies.
Gentamicin Sulfate is a fermentation-derived aminoglycoside antibacterial API identified by CAS Number 1405-41-0. It is a sulfate salt mixture containing gentamicin C components and acts primarily by disrupting bacterial protein synthesis through binding to the 30S ribosomal subunit.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | ≤14.0% |
| Heavy Metals | ≤20 ppm |
| pH (1% Solution) | 3.5 – 5.5 |
| Water Content | ≤14.0% |
| Melting Point | +107° to +121° |