Gentamicin Sulphate API is an aminoglycoside antibiotic produced by fermentation of Micromonospora purpurea. It is a mixture of closely related aminoglycoside components, principally Gentamicin C1, Gentamicin C1a and Gentamicin C2. It exhibits broad-spectrum antibacterial activity against susceptible Gram-negative and selected Gram-positive bacteria.
Gentamicin acts by binding to the 30S subunit of bacterial ribosomes, interfering with protein synthesis and causing misreading of bacterial messenger RNA. This produces abnormal proteins and ultimately leads to bacterial cell death.
Gentamicin Sulphate is widely used in pharmaceutical formulations including injectable preparations, ophthalmic preparations, topical preparations and other antimicrobial dosage forms.
| Property | Value |
|---|---|
| API Name | Gentamicin Sulphate |
| CAS Number | 1405-41-0 |
| Chemical Class | Aminoglycoside Antibiotic |
| Pharmacological Class | Aminoglycoside Antibacterial |
| Source | Fermentation product of Micromonospora purpurea |
| Major Components | Gentamicin C1, C1a and C2 |
| Appearance | White to off-white powder |
| Water Solubility | Freely soluble in water |
| pH | 3.5–5.5 |
| Molecular Formula | Variable mixture; commonly represented as C21H43N5O7·H2SO4 for the C1 component |
| Molecular Weight | Approximately 575.67 g/mol for Gentamicin C1 sulfate |
Important: Gentamicin Sulphate is a mixture of related components, so a single molecular formula and molecular weight do not completely describe the pharmaceutical material.
| 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 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 3.5–5.5 |
| Individual Impurity | NMT 2.0% |
| Total Impurities | NMT 5.0% |
| Water Content | NMT 15.0% |