Netilmicin Sulfate is a semi-synthetic aminoglycoside antibacterial active pharmaceutical ingredient (API) derived from sisomicin. It belongs to the aminoglycoside class of antibacterial agents and is active against susceptible Gram-negative bacteria.
Netilmicin Sulfate is used in pharmaceutical development and manufacture of antibacterial formulations and is particularly associated with treatment of serious infections caused by susceptible aerobic Gram-negative organisms.
Netilmicin Sulfate is a specialized aminoglycoside antibacterial API used in pharmaceutical formulation development, antimicrobial research, analytical testing and pharmaceutical manufacturing.
The USP monograph defines Netilmicin Sulfate as the sulfate salt and specifies potency based on the netilmicin active moiety. USP states that it has a potency equivalent to not less than 595 µg of netilmicin per mg, calculated on the dried basis.
CAS Number: 56391-57-2
Molecular Formula: (C₂₁H₄₁N₅O₇)₂·5H₂SO₄
Molecular Weight: 1441.55 g/mol
Active Moiety Formula: C₂₁H₄₁N₅O₇
Active Moiety Molecular Weight: 475.6 g/mol
Chemical Name: Netilmicin sulfate (2:5)
Drug Class: Aminoglycoside Antibacterial
Therapeutic Class: Aminoglycoside Antibiotic
Therapeutic Area: Infectious Diseases
Molecule Type: Semi-synthetic Aminoglycoside
Development Code / Synonym: Netromycin / SCH 20569
USP identifies the sulfate salt with CAS 56391-57-2 and molecular weight 1441.55 g/mol, while PubChem gives the free netilmicin active moiety as CAS 56391-56-1, formula C₂₁H₄₁N₅O₇, and molecular weight 475.6 g/mol.
Netilmicin is an aminoglycoside that exerts antibacterial activity primarily through interaction with bacterial ribosomes.
Its antibacterial mechanism includes:
Netilmicin Sulfate API is relevant to:
Netilmicin is associated primarily with antibacterial activity against susceptible aerobic Gram-negative bacteria. Its use is determined by bacterial susceptibility, clinical indication and applicable regulatory requirements.
Netilmicin Sulfate is available as a pharmaceutical active ingredient for development of formulations such as sterile preparations.
Netilmicin Sulfate is described in the Ph. Eur. material as a white or yellowish-white powder and is very hygroscopic. It is very soluble in water and practically insoluble in acetone and alcohol.
A controlled Netilmicin Sulfate API manufacturing process may involve:
Typical Netilmicin Sulfate API testing may include:
Store Netilmicin Sulfate API in a tightly closed container protected from moisture, under controlled pharmaceutical storage conditions.
Because the substance is described as very hygroscopic, moisture protection is particularly important during storage and handling.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 15.0% |
| Residue on Ignition | NMT 1.0% |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 5.0% |
| Water Content | NMT 15.0% |
| Specific Rotation | +88.0° to +96.0° |