Micronomicin API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Micronomicin API

Micronomicin is an aminoglycoside antibiotic and an analogue of gentamicin. It is also known as Gentamicin C2b and is associated with antibacterial activity against susceptible bacterial organisms. Micronomicin is an approved drug in Japan and has been used particularly in ophthalmic and systemic antibacterial applications.

Micronomicin is a specialized antibacterial pharmaceutical API belonging to the aminoglycoside class and is relevant to pharmaceutical development, microbiological research and formulation of antimicrobial products.

Micronomicin API Manufacturer in India

Micronomicin is a specialized aminoglycoside API requiring stringent control of identity, potency, related substances, moisture, residual solvents and microbiological quality.

Chemical Information

CAS Number: 52093-21-7
Molecular Formula: C20H41N5O7
Molecular Weight: 463.58 g/mol
Chemical Class: Aminoglycoside Antibiotic
Synonym: Gentamicin C2b
Other Synonyms: Sagamicin, XK-62-2
Therapeutic Class: Aminoglycoside Antibacterial
Therapeutic Area: Infectious Diseases / Ophthalmology
Molecule Type: Natural Product / Aminoglycoside

PubChem and the Royal Society of Chemistry's Merck Index list the molecular formula as C20H41N5O7 and molecular weight at approximately 463.58 g/mol.

Mechanism of Action

Micronomicin is an aminoglycoside antibacterial agent. Aminoglycosides exert their antibacterial effect primarily by binding to bacterial 30S ribosomal subunits, interfering with protein synthesis and causing production of abnormal proteins.

This results in:

  • Inhibition of bacterial protein synthesis
  • Misreading of bacterial mRNA
  • Disruption of bacterial cellular function
  • Bactericidal activity against susceptible organisms

Pharmaceutical Applications

Micronomicin API is associated with:

  • Bacterial infections
  • Ophthalmic antibacterial preparations
  • Aminoglycoside antibiotic research
  • Antimicrobial pharmaceutical development
  • Microbiological research
  • Infectious-disease drug development

Micronomicin has been marketed in Japan and has been used in ophthalmic preparations; sources also describe systemic administration.

Dosage Form Applications

Micronomicin has been used in pharmaceutical preparations including:

  • Ophthalmic preparations
  • Injectable formulations
  • Other antimicrobial formulations depending on the market and approved product

Physical Characteristics

Micronomicin is an aminoglycoside compound with high polarity. The reported molecular weight is 463.58 g/mol, and the compound has 12 defined stereocenters.

Manufacturing Process

Micronomicin is a naturally derived aminoglycoside antibiotic. A controlled manufacturing process may involve:

  1. Qualified microbial production system
  2. Fermentation
  3. Separation of the antibiotic-containing broth
  4. Clarification and filtration
  5. Purification
  6. Isolation of Micronomicin
  7. Concentration
  8. Drying
  9. Final analytical testing
  10. Pharmaceutical-grade packaging

Quality Control Testing

Typical Micronomicin API quality testing may include:

  • Identification by suitable chromatographic methods
  • IR identification
  • Assay / potency
  • Related substances
  • Water content
  • Residual solvents
  • Sulfated ash / residue on ignition
  • Elemental impurities
  • Microbiological quality
  • Endotoxin testing where applicable
  • Stability testing

Storage

Store Micronomicin API in a tightly closed pharmaceutical container, protected from excessive moisture, heat and direct light. Exact storage conditions should follow the validated stability data and applicable product specification.

Pharmaceutical Research

Micronomicin is relevant to research involving:

  • Aminoglycoside antibiotics
  • Bacterial protein synthesis
  • 30S ribosomal subunits
  • Antibacterial pharmacology
  • Ophthalmic antibiotics
  • Gentamicin analogues
  • Antimicrobial resistance
  • Infectious-disease research

Micronomicin API Summary

Micronomicin is an aminoglycoside antibacterial agent, also known as Gentamicin C2b, with CAS Number 52093-21-7, molecular formula C20H41N5O7, and molecular weight 463.58 g/mol. It is associated particularly with ophthalmic antibacterial applications and is marketed in Japan.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Get Bulk Quote via WhatsApp