Nifurtoinol API Manufacturer in India

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Nifurtoinol API

Nifurtoinol is a synthetic nitrofuran antibacterial active pharmaceutical ingredient (API). Also known as hydroxymethylnitrofurantoin, Nifurtoinol is a nitrofuran derivative associated with antibacterial activity and has historically been used in the treatment of urinary tract infections.

Nifurtoinol is chemically classified as a substituted hydantoin nitrofuran derivative. It contains a 5-nitrofuran moiety linked to a hydroxymethyl-substituted imidazolidine-2,4-dione structure.

Nifurtoinol API Manufacturer in India

Nifurtoinol is a specialized antibacterial pharmaceutical API relevant to nitrofuran research, urinary-tract-infection formulations and pharmaceutical analytical applications.

The compound is recognized in pharmaceutical and pharmacological databases under CAS 1088-92-2 and ATC code J01XE02.

Chemical Information

CAS Number: 1088-92-2

Molecular Formula: C₉H₈N₄O₆

Molecular Weight: 268.18 g/mol

Chemical Name: 3-(Hydroxymethyl)-1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione

IUPAC Name: 3-(Hydroxymethyl)-1-[(5-nitrofuran-2-yl)methylideneamino]imidazolidine-2,4-dione

Synonym: Hydroxymethylnitrofurantoin

Drug Class: Nitrofuran Antibacterial

Therapeutic Class: Antibacterial

Therapeutic Area: Infectious Diseases / Urinary Tract Infections

Molecule Type: Synthetic Small Molecule

ATC Code: J01XE02

IUPHAR/BPS and NCATS support the CAS number, molecular formula, molecular weight and chemical identity of Nifurtoinol.

Mechanism of Action

Nifurtoinol belongs to the nitrofuran class of antibacterial compounds. Its antibacterial activity is associated with metabolic reduction of the nitro group and formation of reactive intermediates.

Its activity may involve:

  • Reduction of the nitro group
  • Formation of reactive metabolites
  • Oxidative damage within susceptible microorganisms
  • Disruption of bacterial cellular processes
  • Interference with bacterial growth
  • Antibacterial activity against susceptible organisms

The precise molecular mechanisms of nitrofuran antibacterial activity can vary according to the organism and experimental conditions.

Pharmaceutical Applications

Nifurtoinol API is relevant to:

  • Antibacterial pharmaceutical formulations
  • Urinary tract infection research
  • Nitrofuran antibacterial research
  • Antimicrobial drug development
  • Pharmaceutical formulation development
  • Microbiological research
  • API analytical testing
  • Pharmaceutical research and development
  • Antibacterial drug discovery
  • Quality-control applications

Urinary Tract Infection Applications

Nifurtoinol has historically been used as an antibacterial medicine for urinary tract infections. NCATS identifies Nifurtoinol as an antibacterial drug used for urinary tract infections.

Its historical pharmaceutical application is associated with the urinary tract, although current clinical use depends on the regulatory status and approved indications in the relevant market.

Nitrofuran Antibacterial Activity

The nitrofuran group is a key structural feature of Nifurtoinol.

Nitrofuran antibacterial compounds can undergo enzymatic reduction inside susceptible microorganisms, producing reactive intermediates that contribute to antimicrobial activity.

Nifurtoinol is therefore relevant to research involving nitrofuran chemistry, antimicrobial activity and bacterial susceptibility.

Physical Characteristics

Nifurtoinol is a synthetic organic compound with molecular weight approximately 268.18 g/mol. IUPHAR/BPS reports a topological polar surface area of approximately 129.49 Ų and XLogP of approximately 0.33.

Reference chemical data describe Nifurtoinol as forming yellow crystals and report decomposition around 258°C.

Solubility

Published reference data indicate that Nifurtoinol has limited water solubility. One chemical reference reports water solubility of approximately 0.33 g/L at 22°C.

Because solubility can vary with temperature, pH, particle size and experimental methodology, this research value should not automatically be treated as a pharmaceutical release specification.

Manufacturing Process

A controlled Nifurtoinol API manufacturing process may involve:

  1. Qualification of starting materials
  2. Preparation of nitrofuran intermediates
  3. Preparation of substituted hydantoin intermediate
  4. Controlled condensation reaction
  5. Formation of the nitrofurfurylidene-amino linkage
  6. Reaction monitoring
  7. Purification
  8. Crystallization
  9. Filtration and washing
  10. Controlled drying
  11. Milling, where required
  12. Final analytical testing
  13. GMP-compliant packaging

Quality Control Testing

Typical Nifurtoinol API quality control may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Individual impurities
  • Total impurities
  • Loss on drying
  • Water content
  • Residue on ignition / sulfated ash
  • Residual solvents
  • Elemental impurities
  • Particle-size testing, where applicable
  • Stability testing

Exact acceptance criteria should be taken from the current approved API specification or applicable pharmacopoeial monograph.

Storage

Store Nifurtoinol API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Commercial storage conditions should be established from 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 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point Approximately 258°C
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