Nitroxoline API Manufacturer in India

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

Nitroxoline API

Nitroxoline is a synthetic 8-hydroxyquinoline derivative with antibacterial activity, particularly associated with urinary tract infections. It is also classified as a urinary anti-infective and belongs to the hydroxyquinoline group of antimicrobial compounds.

Nitroxoline is used as an active pharmaceutical ingredient for pharmaceutical formulation development, antibacterial research and analytical applications.

Nitroxoline API Manufacturer in India

Nitroxoline is a specialized urinary antibacterial API used in the development and manufacture of pharmaceutical formulations. Its important quality attributes include chemical identity, assay, related substances, residual solvents, water content and physical characteristics.

Chemical Information

CAS Number: 4008-48-4
Molecular Formula: C₉H₆N₂O₃
Molecular Weight: 190.16 g/mol
Chemical Name: 5-Nitroquinolin-8-ol
Synonyms: 8-Hydroxy-5-nitroquinoline; 5-Nitro-8-quinolinol
Drug Class: Urinary Antibacterial
Therapeutic Class: Anti-infective
Therapeutic Area: Infectious Diseases / Urology
Molecule Type: Synthetic Small Molecule

The CAS number, molecular formula and molecular weight are confirmed by PubChem.

Mechanism of Action

Nitroxoline exhibits antibacterial activity through mechanisms associated with metal-ion chelation and interference with bacterial enzymes and essential cellular processes. It has activity against susceptible microorganisms associated with urinary tract infections.

Nitroxoline has also been reported to interact with bacterial DNA-related and enzyme-mediated processes, contributing to its antimicrobial effects.

Pharmaceutical Applications

Nitroxoline API is used for:

  • Urinary tract infection pharmaceutical formulations
  • Urinary antibacterial drug development
  • Antimicrobial research
  • Infectious-disease pharmaceutical research
  • Hydroxyquinoline research
  • Pharmaceutical formulation development
  • Analytical and quality-control testing

Nitroxoline is classified by the WHO ATC system under J01XX07, within other antibacterials for systemic use.

Physical Characteristics

Nitroxoline is a solid crystalline compound with a reported melting point of approximately 180°C.

A reported experimental aqueous solubility value is approximately 2.73 g/L, although solubility can vary with pH, temperature and experimental methodology.

Pharmaceutical Research

Nitroxoline is relevant to research involving:

  • Urinary tract infections
  • Antibacterial drug development
  • Hydroxyquinoline compounds
  • Metal-ion chelation
  • Antimicrobial pharmacology
  • Bacterial enzyme inhibition
  • Pharmaceutical formulation development
  • Analytical research
  • Infectious-disease research

Quality Control Testing

Typical Nitroxoline API quality-control testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Organic impurities
  • Residual solvents
  • Water content
  • Residue on ignition, where applicable
  • Elemental impurities
  • Particle-size analysis, where applicable
  • Stability testing

Final acceptance criteria should be based on the applicable pharmacopoeial monograph or validated API specification rather than generic limits.

Storage

Store Nitroxoline API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage requirements should follow validated stability data and the applicable API specification.

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 0.1%
Individual Impurity NMT 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
Melting Point 180°C
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