Mafenide Acetate is a topical sulfonamide antibacterial agent used primarily for the prevention and treatment of bacterial infections associated with burns. It is the acetate salt of mafenide and is formulated for topical application to burned tissue.
Mafenide Acetate has broad antibacterial activity against a variety of Gram-positive and Gram-negative organisms. Unlike many other antibacterial agents, mafenide can penetrate burn eschar, making it useful in topical management of burn wounds where bacterial proliferation can interfere with healing.
Mafenide Acetate is a synthetic sulfonamide compound with the molecular formula C9H14N2O3S and a molecular weight of approximately 230.28 g/mol. Its CAS Number is 13009-99-9.
The compound is the acetate salt of mafenide and is generally supplied as a pharmaceutical-grade active ingredient for topical pharmaceutical formulations.
Mafenide is converted to its active form and exerts antibacterial activity through interference with bacterial metabolic processes. It inhibits bacterial carbonic anhydrase and interferes with bacterial growth and survival.
Its mechanism and ability to penetrate burn eschar contribute to its usefulness in controlling bacterial infection in burn wounds.
Mafenide Acetate is primarily used in topical pharmaceutical preparations for second- and third-degree burns. It is applied to burned areas to reduce the risk of bacterial infection and to control established bacterial infections.
The drug is particularly useful in burn care because it can penetrate devascularized burn tissue and eschar.
Mafenide Acetate API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. Appropriate controls should be established for related substances, degradation products and residual solvents.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Mafenide Acetate should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Mafenide Acetate API may be supplied for qualified pharmaceutical manufacturing, topical formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Mafenide Acetate API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 6.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 165–170 °C |