Nifurtimox API Manufacturer in India

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

Nifurtimox API

Nifurtimox is a synthetic nitrofuran antiprotozoal active pharmaceutical ingredient (API). It is primarily used in the treatment of Chagas disease caused by Trypanosoma cruzi. Nifurtimox is chemically characterized as a nitrofuran derivative containing a thiomorpholine 1,1-dioxide moiety. PubChem identifies Nifurtimox with CAS 23256-30-6, molecular formula C₁₀H₁₃N₃O₅S, and molecular weight 287.29 g/mol.

Nifurtimox API Manufacturer in India

Nifurtimox is an established antiparasitic pharmaceutical API used in the development and manufacture of formulations for Chagas disease treatment and in pharmaceutical research involving Trypanosoma cruzi.

Nifurtimox is recognized by the FDA as an antiprotozoal medicine for the treatment of Chagas disease in pediatric patients, and it is included in WHO-related essential-medicine information for Chagas disease treatment.

Chemical Information

CAS Number: 23256-30-6

Molecular Formula: C₁₀H₁₃N₃O₅S

Molecular Weight: 287.29 g/mol

Chemical Name: 3-Methyl-4-[(5-nitro-2-furyl)methyleneamino]thiomorpholine 1,1-dioxide

IUPAC Name: (E)-N-(3-methyl-1,1-dioxo-1,4-thiazinan-4-yl)-1-(5-nitrofuran-2-yl)methanimine

Drug Class: Nitrofuran Antiprotozoal

Therapeutic Class: Antiprotozoal

Therapeutic Area: Infectious Diseases / Parasitic Diseases

Molecule Type: Synthetic Small Molecule

ATC Code: P01CC01

PubChem and the FDA GSRS database support the chemical identity, CAS number, molecular formula and molecular weight.

Mechanism of Action

Nifurtimox is a nitrofuran derivative whose antiparasitic activity is associated with reduction of its nitro group and formation of reactive intermediates within susceptible organisms.

Its activity involves:

  • Nitro-group reduction
  • Formation of reactive metabolites
  • Oxidative stress within the parasite
  • Damage to cellular macromolecules
  • Disruption of essential parasite metabolic processes
  • Inhibition of Trypanosoma cruzi survival and replication

The exact molecular mechanisms responsible for all of Nifurtimox's antiparasitic effects continue to be studied.

Pharmaceutical Applications

Nifurtimox API is relevant to:

  • Chagas disease formulations
  • Antiprotozoal drug development
  • Trypanosoma cruzi research
  • Antiparasitic pharmaceutical development
  • Infectious-disease research
  • Pharmaceutical formulation development
  • API manufacturing
  • Analytical testing
  • Antiprotozoal drug discovery
  • Pharmaceutical research and development

Antiprotozoal Applications

Nifurtimox is primarily associated with treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. PubChem identifies it as an FDA-approved antiprotozoal medicine for specified pediatric patients.

Nitrofuran Activity

Nifurtimox belongs to the nitrofuran class of antimicrobial and antiprotozoal compounds.

Its nitrofuranyl group is important to its biological activity because enzymatic reduction can generate reactive intermediates capable of producing cellular damage in susceptible parasites.

Physical Characteristics

Nifurtimox is a synthetic crystalline small molecule with a molecular weight of 287.29 g/mol and molecular formula C₁₀H₁₃N₃O₅S.

For CMS appearance and physical-property specifications, the exact material should be matched against the applicable pharmacopoeial or validated manufacturer specification rather than using an unverified generic description.

Solubility

Nifurtimox has limited aqueous solubility. Because published values can vary according to experimental conditions, temperature and solid form, the commercial API CMS should use the applicable validated solubility description rather than treating a single research value as a release specification.

Manufacturing Process

A controlled Nifurtimox API manufacturing process may involve:

  1. Qualification of starting materials
  2. Preparation of nitrofuran intermediates
  3. Preparation of substituted thiomorpholine intermediates
  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. Final analytical testing
  12. GMP-compliant packaging

Quality Control Testing

Typical Nifurtimox API testing may include:

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

Storage

Store Nifurtimox 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 according to validated stability data and the applicable approved 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 124–126°C
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