Neomycin Sulfate is an aminoglycoside antibacterial pharmaceutical API produced from substances obtained through the growth of Streptomyces fradiae. It is a mixture of neomycin sulfate components, with neomycin B as the principal component, along with neomycin C and smaller amounts of other components.
Neomycin Sulfate has broad antibacterial activity against susceptible microorganisms and is used in pharmaceutical formulations including topical, ophthalmic and oral preparations. Its applications include antibacterial treatment and prevention of susceptible bacterial infections, depending on the dosage form and approved indication.
Neomycin Sulfate is a well-characterized aminoglycoside antibiotic API used in pharmaceutical formulation development, antibacterial research, analytical testing and manufacturing.
The API is particularly characterized by its microbiological potency, rather than a conventional percentage assay alone. The current USP monograph specifies a potency equivalent to NLT 600 µg of neomycin per mg, calculated on the dried basis.
CAS Number: 1405-10-3
Molecular Formula: C₂₃H₄₈N₆O₁₇S
Molecular Weight: 712.70 g/mol
Principal Component: Neomycin B sulfate
Drug Class: Aminoglycoside Antibiotic
Therapeutic Class: Antibacterial
Therapeutic Area: Infectious Diseases
Molecule Type: Natural-source antibiotic mixture / aminoglycoside sulfate
Synonyms: Neomycin Sulphate, Neomycin B Sulfate, Framycetin-related neomycin sulfate
PubChem lists CAS 1405-10-3, molecular formula C₂₃H₄₈N₆O₁₇S, and molecular weight 712.7 g/mol for the represented sulfate species. Pharmacopoeial references commonly express the substance on a free-base basis (614.65) because Neomycin Sulfate is a mixture of sulfate salts with variable sulfate association.
Neomycin is an aminoglycoside antibiotic that acts primarily by interfering with bacterial protein synthesis.
Its antibacterial activity involves:
Neomycin Sulfate API is relevant to:
Neomycin has activity against a range of susceptible bacteria and is incorporated into several pharmaceutical dosage forms.
Topical and ophthalmic formulations may use neomycin in combination with other active ingredients. Oral neomycin has also been used for specific gastrointestinal applications because of its limited systemic absorption when administered orally.
The exact therapeutic application depends on the approved dosage form, regulatory labeling and susceptibility of the target organisms.
Neomycin belongs to the aminoglycoside antibiotic family. Unlike many synthetic small-molecule APIs, Neomycin Sulfate is a fermentation-derived antibiotic complex.
The principal active component is neomycin B, while neomycin C and smaller components are also present. This compositional nature is one reason pharmaceutical specifications emphasize chromatographic composition and microbiological potency.
Neomycin Sulfate is described as a white or yellowish-white powder and is hygroscopic. It is freely soluble in water and very slightly soluble in ethanol, while being practically insoluble in acetone and ether.
Because the material is hygroscopic, moisture control is an important quality attribute during handling, packaging and storage.
Neomycin Sulfate is produced through a controlled fermentation and purification process rather than conventional total chemical synthesis.
A pharmaceutical manufacturing process may involve:
Typical Neomycin Sulfate API testing may include:
The USP monograph specifically includes identification, composition/impurity testing and microbiological assay, while pharmacopoeial specifications also control pH, loss on drying and sulfate-related characteristics.
Store Neomycin Sulfate API in a tightly closed, light-resistant container, protected from moisture and excessive heat.
The International Pharmacopoeia notes that Neomycin Sulfate is hygroscopic and can gradually degrade when exposed to humid conditions, with degradation increasing at higher temperatures.
Neomycin Sulfate is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 8.0% |
| Residue on Ignition | NMT 1.0% |
| pH (1% Solution) | 5.0 – 7.5 |
| Individual Impurity | NMT 2.0% |
| Water Content | NMT 8.0% |
| Specific Rotation | +53.5° to +59.0° |