Isepamicin is a semisynthetic aminoglycoside antibiotic structurally related to gentamicin B. It exhibits antibacterial activity against a range of Gram-negative bacteria and was developed to provide improved resistance to certain aminoglycoside-inactivating enzymes.
Isepamicin acts primarily by binding to the 30S bacterial ribosomal subunit, interfering with bacterial protein synthesis and producing a bactericidal effect.
Isepamicin is a specialized aminoglycoside antibacterial API manufactured through controlled chemical and/or semisynthetic processes followed by purification and analytical characterization.
Important quality attributes include identity, assay, related substances, water content, sulfate content where applicable, residual solvents, elemental impurities, microbial quality and stability.
CAS Number: 58152-03-7
Molecular Formula: C22H43N5O12
Molecular Weight: 585.60 g/mol
Drug Class: Aminoglycoside Antibiotic
Pharmacological Class: Aminoglycoside Antibacterial
Therapeutic Class: Antibacterial Agent
Therapeutic Area: Infectious Diseases
Isepamicin binds to the 30S subunit of bacterial ribosomes. This interferes with accurate translation of messenger RNA and results in the production of abnormal proteins.
Its antibacterial activity ultimately leads to:
Isepamicin is therefore considered a bactericidal aminoglycoside.
Isepamicin has activity primarily against susceptible aerobic Gram-negative organisms. Its activity against particular bacterial strains depends on susceptibility patterns and resistance mechanisms.
A key characteristic of isepamicin is its relative stability against certain aminoglycoside-modifying enzymes, although resistance can still occur through other mechanisms.
Isepamicin has been investigated or used in selected settings for treatment of serious bacterial infections, particularly infections caused by susceptible Gram-negative organisms.
Potential clinical applications include:
Use depends on local regulatory approval, antimicrobial susceptibility and applicable clinical guidelines.
Like other aminoglycosides, isepamicin demonstrates:
Typical production may involve:
Isepamicin API quality evaluation may include:
Isepamicin should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage requirements should be established from validated stability studies.
Isepamicin is relevant to research involving:
Isepamicin is a semisynthetic aminoglycoside antibiotic with CAS Number 58152-03-7, molecular formula C22H43N5O12, and molecular weight 585.60 g/mol. It acts primarily by binding to the bacterial 30S ribosomal subunit and inhibiting accurate protein synthesis.
| 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% |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | ≤5.0% |