Nifuratel is a synthetic nitrofuran derivative with antimicrobial and antiprotozoal activity. It is used as a pharmaceutical active ingredient in the development of formulations for infections caused by susceptible bacteria, protozoa and certain fungi.
Nifuratel is particularly associated with pharmaceutical preparations for urogenital infections and is used in several countries as an antimicrobial drug substance.
Nifuratel is a specialized antimicrobial API with a defined chemical structure and established pharmaceutical applications. Key quality attributes include identity, assay, related substances, water content, sulfated ash and other applicable pharmaceutical quality parameters.
CAS Number: 4936-47-4
Molecular Formula: C10H11N3O5S
Molecular Weight: 285.28 g/mol
Chemical Name: 5-[(Methylthio)methyl]-3-[(5-nitro-2-furyl)methyleneamino]-2-oxazolidinone
Drug Class: Nitrofuran Antimicrobial
Therapeutic Area: Anti-infective / Gynecology / Urology
Molecule Type: Synthetic Small Molecule
Nifuratel is a nitrofuran antimicrobial compound. Its nitro group can undergo reduction within susceptible microorganisms, producing reactive intermediates that can interfere with essential microbial cellular processes.
Its antimicrobial spectrum includes activity against certain:
Nifuratel's activity against susceptible microorganisms makes it useful in pharmaceutical development for urogenital infections.
Nifuratel API is used in pharmaceutical development for:
Nifuratel is generally described as a yellow crystalline powder. It is characterized by limited aqueous solubility and greater solubility in selected organic solvents. Physical properties should be controlled according to the applicable API specification.
A controlled Nifuratel API manufacturing process may involve:
Typical Nifuratel API quality-control testing may include:
Nifuratel is relevant to research involving:
Store Nifuratel 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 product specification.
| 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 176–180°C |