Neomycin Sulphate is an aminoglycoside antibacterial pharmaceutical API obtained from fermentation-derived neomycin and formulated as a sulfate salt. It consists primarily of neomycin B, together with neomycin C and other related components.
Neomycin Sulphate acts by interfering with bacterial protein synthesis through interaction with the bacterial 30S ribosomal subunit. It is used in pharmaceutical formulations for antibacterial applications, including topical, ophthalmic and selected oral preparations.
Neomycin Sulphate is a well-characterized aminoglycoside antibiotic API used in pharmaceutical formulation development, manufacturing, microbiological research and analytical quality control.
Unlike conventional synthetic small-molecule APIs where assay is commonly expressed as a percentage, Neomycin Sulphate is principally characterized by microbiological potency and component composition. Pharmacopoeial standards specify a minimum potency of 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
Drug Class: Aminoglycoside Antibiotic
Therapeutic Class: Antibacterial
Therapeutic Area: Infectious Diseases
Molecule Type: Fermentation-derived antibiotic mixture
Synonyms: Neomycin Sulfate, Neomycin Sulphate, Neomycin B Sulfate
Neomycin Sulphate exerts antibacterial activity primarily through inhibition of bacterial protein synthesis.
Its activity involves:
Neomycin Sulphate API is relevant to:
Neomycin has antibacterial activity against various susceptible Gram-positive and Gram-negative microorganisms.
Because systemic absorption of neomycin can be limited or clinically significant depending on the route of administration, its pharmaceutical applications vary according to dosage form. Topical and ophthalmic formulations are important applications, while oral administration has specific gastrointestinal uses.
The precise therapeutic use should follow the applicable regulatory approval and product labeling.
Neomycin belongs to the aminoglycoside antibiotic class.
The API is not a single chemically uniform synthetic molecule; rather, Neomycin Sulphate contains a mixture of neomycin components, with neomycin B as the principal component. Consequently, pharmaceutical quality control includes both microbiological potency and chromatographic component testing.
Neomycin Sulphate is generally described as a white to yellowish-white hygroscopic powder.
It is freely soluble in water, very slightly soluble in ethanol and practically insoluble in acetone and ether.
Its hygroscopic nature makes moisture protection important during storage and handling.
A controlled Neomycin Sulphate API manufacturing process may involve:
Typical Neomycin Sulphate API testing may include:
Store Neomycin Sulphate API in a tightly closed, moisture-resistant container, protected from excessive heat, humidity and direct light.
Because Neomycin Sulphate is hygroscopic, appropriate moisture protection is particularly important during storage.
Neomycin Sulphate 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 – 7.0 |
| Individual Impurity | NMT 2.0% |
| Water Content | NMT 8.0% |
| Specific Rotation | +53.5° to +59.0° |