Sulfadoxine is a long-acting sulfonamide antibacterial API with established pharmaceutical use, particularly in combination with pyrimethamine for antimalarial therapy. Chemically, Sulfadoxine is 4-amino-N-(5,6-dimethoxy-4-pyrimidinyl)benzenesulfonamide, with CAS Number 2447-57-6, molecular formula C₁₂H₁₄N₄O₄S and molecular weight 310.33 g/mol.
Sulfadoxine belongs to the sulfonamide class and acts by interfering with folate synthesis in susceptible microorganisms. Its long duration of action has made it an important component of combination-based antimalarial formulations.
Sulfadoxine is characterized as a white to off-white crystalline powder. It is chemically identified through spectroscopic and pharmacopoeial analytical procedures. The API is available for pharmaceutical applications subject to applicable pharmacopoeial and customer-specific quality requirements.
The compound has a molecular weight of 310.33 g/mol and CAS Number 2447-57-6. It is also known as Sulphadoxine and Sulfadoxin.
Sulfadoxine is primarily associated with antimicrobial and antimalarial pharmaceutical applications. It is commonly used in combination with pyrimethamine because the two compounds act at sequential stages of the folate pathway.
Sulfadoxine inhibits the utilization of para-aminobenzoic acid in folate synthesis, while pyrimethamine inhibits dihydrofolate reductase. This complementary mechanism provides the pharmacological basis for their combination in antimalarial therapy.
Sulfadoxine API quality can be evaluated through identity testing, assay, loss on drying, residue on ignition, elemental impurity control and related-substance testing.
The USP monograph specifies Sulfadoxine at 99.0–101.0% on a dried basis. USP reference requirements also include loss on drying of not more than 0.5%, residue on ignition of not more than 0.1%, and heavy metals of not more than 20 ppm.
Analytical controls may include:
Swapnroop Drugs and Pharmaceuticals offers pharmaceutical API manufacturing capabilities for Sulfadoxine with quality-focused analytical evaluation and documentation.
Sulfadoxine API can be manufactured and supplied according to applicable pharmacopoeial requirements and agreed customer specifications. Each batch can be supported by appropriate quality documentation and analytical testing based on the applicable specification.
For pharmaceutical companies seeking Sulfadoxine API from an India-based manufacturer, specification alignment, batch consistency, analytical control and documentation are important considerations.
Sulfadoxine API should be packed in suitable, well-closed containers that protect the material from contamination and environmental exposure. Pharmacopoeial guidance recommends preservation in well-closed, light-resistant containers.
Recommended handling includes:
Depending on the agreed supply specification and regulatory requirements, documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API manufacturing with quality systems, analytical testing and documentation designed to support pharmaceutical applications.
Sulfadoxine API is handled according to defined quality requirements, with attention to identity, assay, impurities, physical properties and batch-to-batch consistency.
For Sulfadoxine API requirements, customers can discuss applicable grade, specification, packaging and documentation requirements with Swapnroop Drugs and Pharmaceuticals.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0–101.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Melting Point | 197–200°C |