Sulfamerazine is a sulfonamide antibacterial active pharmaceutical ingredient (API) belonging to the sulfonamide class of antimicrobial compounds. It is chemically identified as 4-amino-N-(4-methyl-2-pyrimidinyl)benzenesulfonamide and has the molecular formula C₁₁H₁₂N₄O₂S, molecular weight 264.30 g/mol and CAS Number 127-79-7.
Sulfamerazine is recognized as a sulfonamide antibacterial and is characterized as a crystalline powder or crystals ranging from white to yellowish-white or pinkish-white.
Sulfamerazine contains a sulfanilamide moiety linked to a 4-methylpyrimidinyl group. Its chemical structure and identity are confirmed by established spectroscopic and chromatographic analytical procedures.
The API has a molecular weight of 264.30 g/mol and is very slightly soluble in water. It is sparingly soluble in acetone, slightly soluble in ethanol and very slightly soluble in methylene chloride. It dissolves in solutions of alkali hydroxides and dilute mineral acids.
Sulfamerazine is associated with antibacterial pharmaceutical applications. Like other sulfonamide antibacterials, it acts as a structural analogue of para-aminobenzoic acid (PABA).
Sulfamerazine competitively inhibits bacterial dihydropteroate synthase, interfering with the bacterial folate synthesis pathway and thereby limiting the formation of folate-dependent metabolites required for bacterial growth.
Quality evaluation of Sulfamerazine API may include identity testing, assay, loss on drying, residue on ignition, heavy-metal or elemental impurity control and related-substance testing.
The Ph. Eur./BP specification defines Sulfamerazine at 99.0–101.0%, calculated with reference to the dried substance. The monograph also specifies its physical characteristics, identification procedures and related-substance controls.
Typical quality controls include:
Swapnroop Drugs and Pharmaceuticals offers pharmaceutical API manufacturing capabilities for Sulfamerazine with quality-focused analytical controls and documentation.
Sulfamerazine API can be handled according to applicable pharmacopoeial requirements and agreed customer specifications. Quality evaluation focuses on identity, assay, moisture, inorganic residue, impurities and other applicable quality attributes.
For pharmaceutical companies requiring Sulfamerazine API from an India-based manufacturer, specification alignment, batch consistency, analytical testing and appropriate documentation are important considerations.
Sulfamerazine should be handled and stored in suitable, tightly closed pharmaceutical packaging that protects the material from environmental exposure.
Recommended handling includes:
Depending on customer and regulatory requirements, documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API manufacturing with quality systems, analytical evaluation and documentation intended to support pharmaceutical applications.
Sulfamerazine API is handled according to defined quality requirements with attention to identity, assay, impurities, physical characteristics and batch-to-batch consistency.
For Sulfamerazine 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) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Melting Point | About 235°C |