Sulfabenzamide API is a synthetic sulfonamide antibacterial active pharmaceutical ingredient belonging to the sulfonamide class of antimicrobial compounds. Chemically, it is identified as N-[(4-aminophenyl)sulfonyl]benzamide, also known as N-sulfanilylbenzamide or N¹-benzoylsulfanilamide. Sulfabenzamide has the molecular formula C₁₃H₁₂N₂O₃S, molecular weight 276.31 g/mol, and CAS Number 127-71-9.
Sulfabenzamide has an established USP-NF monograph. USP specifies that Sulfabenzamide contains not less than 99.0% and not more than 100.5% of C₁₃H₁₂N₂O₃S, calculated on the dried basis.
Sulfabenzamide has historically been used as a topical antimicrobial and is also present as an active ingredient in combination vaginal pharmaceutical preparations. Its sulfonamide structure provides antibacterial activity through interference with bacterial folate synthesis.
Sulfabenzamide is a synthetic sulfonamide antibacterial compound consisting of a sulfanilamide structure substituted with a benzoyl group. Its systematic chemical identity is 4-amino-N-benzoylbenzenesulfonamide. The molecular formula is C₁₃H₁₂N₂O₃S and molecular weight is 276.31 g/mol.
The compound is generally handled as a solid pharmaceutical active ingredient. USP identifies Sulfabenzamide through infrared absorption and a characteristic chemical identification reaction involving sodium bicarbonate. The USP monograph also specifies a melting range of 180–184°C.
Sulfabenzamide has limited water solubility and is more readily handled using suitable pharmaceutical solvents or formulation systems. Published analytical data describe it as insoluble in water under common laboratory conditions.
Sulfabenzamide is primarily associated with topical and intravaginal pharmaceutical applications. It has been used as an antibacterial component in vaginal preparations, including formulations containing combinations of sulfabenzamide, sulfacetamide and sulfathiazole.
Its antimicrobial activity is associated with the sulfonamide class, which interferes with bacterial folate metabolism. Sulfabenzamide may therefore be incorporated into pharmaceutical formulations where an appropriate sulfonamide antibacterial component is required.
The specific use, formulation, dosage and regulatory status depend on the finished pharmaceutical product and applicable market regulations.
Sulfabenzamide belongs to the sulfonamide class of antibacterial agents. Sulfonamides structurally resemble para-aminobenzoic acid (PABA), an important precursor in bacterial folate biosynthesis.
Sulfabenzamide interferes with the bacterial folate pathway by competing with PABA for dihydropteroate synthase. This reduces the formation of dihydrofolate intermediates required for bacterial nucleotide synthesis and consequently inhibits bacterial growth.
Sulfabenzamide is covered by a USP-NF monograph defining its identity, assay and physical-quality requirements. USP specifies an assay range of 99.0–100.5% calculated on the dried basis.
The USP monograph identifies Sulfabenzamide using infrared absorption and a characteristic sodium-bicarbonate identification reaction. It specifies a melting range of 180–184°C and loss on drying NMT 0.5% after drying at 105°C for 2 hours.
Historical USP monograph information also specifies limits for selenium and heavy metals and describes an ordinary-impurities test. Because these requirements can vary with the applicable pharmacopoeial edition and customer specification, the final commercial specification should be aligned with the applicable current standard rather than automatically treating historical limits as universal release criteria.
The USP assay described for Sulfabenzamide is a titrimetric assay using 0.1 N sodium methoxide, rather than an HPLC assay. Therefore, the CMS field should not incorrectly label the compendial assay as "Assay (HPLC)."
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing and quality-support capabilities for Sulfabenzamide, with analytical evaluation aligned with applicable pharmaceutical and customer-specific specifications.
Sulfabenzamide API can be evaluated for identity, assay, loss on drying, melting range and other applicable quality parameters according to the agreed specification and relevant pharmacopoeial requirements.
For pharmaceutical manufacturers looking for Sulfabenzamide API from India, product specifications, analytical documentation and commercial requirements can be evaluated according to the intended formulation and regulatory market.
Sulfabenzamide should be preserved in well-closed, light-resistant containers according to the USP monograph.
Appropriate pharmaceutical-grade packaging should be selected to protect the API from light, moisture and environmental exposure during storage and transportation. Storage conditions should follow the approved product specification and stability data.
Depending on applicable customer and regulatory requirements, documentation may include:
Sulfabenzamide is an established sulfonamide antibacterial API with a USP-NF monograph defining its identity, assay and important physical-quality characteristics. USP specifies 99.0–100.5% assay on the dried basis and NMT 0.5% loss on drying.
Swapnroop Drugs and Pharmaceuticals focuses on controlled pharmaceutical API manufacturing, analytical quality evaluation and documentation support for customers seeking Sulfabenzamide for pharmaceutical applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0–100.5% |
| Loss on Drying | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Melting Point | 180–184°C |