Sulfaguanidine API is a synthetic sulfonamide antibacterial active pharmaceutical ingredient containing a guanidine moiety. It is chemically identified as 2-(4-aminophenyl)sulfonylguanidine and is also known as N¹-Guanylsulfanilamide or Sulfanilylguanidine. Sulfaguanidine has the molecular formula C₇H₁₀N₄O₂S, molecular weight 214.25 g/mol, and CAS Number 57-67-0.
Sulfaguanidine belongs to the sulfonamide class of antibacterial compounds. It has historically been used for intestinal and enteric bacterial infections because of its relatively poor absorption from the gastrointestinal tract. It is also associated with veterinary pharmaceutical applications.
The current British Pharmacopoeia/Ph. Eur. monograph describes Sulfaguanidine as a sulfonamide antibacterial and specifies a content of 99.0–101.0%, calculated with reference to the dried substance.
Sulfaguanidine is a guanidine derivative of sulfanilamide containing a para-amino phenyl group linked to a sulfonylguanidine moiety. Its molecular formula is C₇H₁₀N₄O₂S, with a molecular weight of approximately 214.25 g/mol.
According to the BP 2025 / Ph. Eur. monograph, Sulfaguanidine is described as a white or almost white, fine crystalline powder. It is very slightly soluble in water, slightly soluble in acetone, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. It dissolves in dilute solutions of mineral acids.
The pharmacopoeial identification includes infrared absorption and a melting-point requirement of 189–193°C, determined on the dried substance.
Sulfaguanidine is a sulfonamide antibacterial API historically used in the management of susceptible bacterial infections of the intestinal tract. Its limited systemic absorption has been an important characteristic in its traditional pharmaceutical use.
Sulfaguanidine has been associated with treatment of bacillary dysentery and other enteric infections, and it has also been used in veterinary pharmaceutical applications.
The actual indication, dosage, formulation, target species and regulatory status depend on the finished pharmaceutical product and the requirements of the applicable market.
Sulfaguanidine belongs to the sulfonamide class of antibacterial agents. Sulfonamides act as structural analogues of para-aminobenzoic acid (PABA) and interfere with bacterial folate biosynthesis.
By inhibiting the bacterial folate pathway, sulfonamide compounds interfere with the production of folate-dependent metabolites required for nucleic-acid synthesis and bacterial growth.
Sulfaguanidine therefore produces antibacterial activity through interference with bacterial folate metabolism.
Sulfaguanidine is covered by a British Pharmacopoeia / European Pharmacopoeia monograph (Ph. Eur. monograph 1476). The monograph specifies that Sulfaguanidine contains not less than 99.0% and not more than 101.0% of the active substance, calculated with reference to the dried substance.
Identification is performed using infrared absorption spectrophotometry, together with pharmacopoeial identification reactions. The melting point is specified at 189–193°C on the dried substance.
The BP/Ph. Eur. related-substances procedure uses thin-layer chromatography (TLC). Under the monograph conditions, any individual additional spot is controlled against reference concentrations corresponding to 0.5%, with at most one such spot permitted to exceed the 0.25% reference level.
The monograph specifies loss on drying NMT 8.0%, determined at 105°C, and sulfated ash NMT 0.1%.
The pharmacopoeial assay is based on determination of primary aromatic amino-nitrogen, using sodium nitrite titration, rather than an HPLC assay.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing and quality-support capabilities for Sulfaguanidine, with analytical evaluation aligned with applicable pharmacopoeial and customer-specific requirements.
Sulfaguanidine API can be evaluated for identity, assay, related substances, loss on drying, sulfated ash, melting range and other applicable quality parameters according to the agreed specification.
For pharmaceutical manufacturers seeking Sulfaguanidine API from India, product specifications, analytical documentation and commercial requirements can be evaluated according to the intended application and applicable regulatory market.
Sulfaguanidine should be stored protected from light, consistent with the BP/Ph. Eur. monograph.
Suitable pharmaceutical-grade packaging should be selected to protect the API from light and environmental exposure during storage and transportation. Packaging configuration and storage conditions should follow the approved product specification and available stability data.
Depending on customer and regulatory requirements, documentation may include:
Sulfaguanidine is an established sulfonamide antibacterial API with a BP/Ph. Eur. monograph defining its identity, assay, related substances and physical-quality requirements. The current referenced monograph specifies 99.0–101.0% assay on the dried basis, NMT 8.0% loss on drying and NMT 0.1% sulfated ash.
Swapnroop Drugs and Pharmaceuticals focuses on controlled pharmaceutical API manufacturing, analytical quality evaluation and documentation support for customers seeking Sulfaguanidine for pharmaceutical and veterinary applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0–101.0% |
| Loss on Drying | NMT 8.0% |
| Heavy Metals | NMT 20 ppm |
| Melting Point | 189–193°C |
| Solubility | Very slightly soluble in water; slightly soluble in acetone; very slightly soluble in ethanol (96%); practically insoluble in methylene chloride; soluble in dilute mineral acids |