Swapnroop Drugs & Pharmaceuticals offers Bromfenac Sodium API for pharmaceutical manufacturing, ophthalmic formulation development and research applications.
Bromfenac Sodium is the sodium salt of bromfenac, a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory activity. Bromfenac inhibits cyclooxygenase enzymes and reduces prostaglandin production associated with ocular inflammation and pain. (pubchem.ncbi.nlm.nih.gov)
Bromfenac Sodium used in ophthalmic products is commonly supplied as the sodium salt sesquihydrate. The marketed ophthalmic substance is chemically described as sodium 2-amino-3-(4-bromobenzoyl)phenylacetate sesquihydrate.
The molecular formula of bromfenac sodium sesquihydrate is C15H11BrNNaO3·1.5H2O and its molecular weight is approximately 383.17 g/mol. The commonly associated CAS number for the sesquihydrate is 120638-55-3. (dailymed.nlm.nih.gov)
Product Name: Bromfenac Sodium
Salt Form: Bromfenac Sodium Sesquihydrate
CAS Number: 120638-55-3
Molecular Formula: C15H11BrNNaO3·1.5H2O
Molecular Weight: 383.17 g/mol
Anhydrous Sodium Salt CAS: 91714-93-1
Free Bromfenac CAS: 91714-94-2
Chemical Class: Non-steroidal anti-inflammatory drug
Therapeutic Category: Ophthalmic NSAID / Anti-inflammatory
Bromfenac Sodium is used in ophthalmic pharmaceutical formulations for the management of ocular pain and postoperative inflammation following cataract surgery. Current ophthalmic product information describes bromfenac sodium as a non-steroidal anti-inflammatory drug for topical ophthalmic administration. (dailymed.nlm.nih.gov)
Bromfenac inhibits cyclooxygenase activity and consequently reduces prostaglandin formation involved in inflammatory responses.
Bromfenac sodium sesquihydrate is described as a bright orange to yellow or yellow to orange crystalline powder. The marketed ophthalmic product information reports that bromfenac sodium is freely soluble in water, soluble in methanol and very slightly soluble in chloroform, dilute acid and dilute base. (dailymed.nlm.nih.gov)
Appearance: White to off-white crystalline powder for the SDP API specification; marketed bromfenac sodium sesquihydrate may appear yellow to orange.
Identification: IR & HPLC
Assay (HPLC): 98.0%–102.0%
Loss on Drying: NMT 1.0%
Residue on Ignition: NMT 0.2%
Heavy Metals: NMT 10 ppm
pH (1% Solution): 2.0–4.0
Individual Impurity: NMT 0.5%
Total Impurities: NMT 1.5%
Water Content: Controlled according to the applicable hydrate specification
Specific Rotation: Not applicable
Melting Point: Approximately 268–272 °C for bromfenac free acid; the sodium sesquihydrate should not be assigned the free-acid melting point.
Solubility: Freely soluble in water; soluble in methanol; very slightly soluble in chloroform, dilute acid and dilute base.
For commercial pharmaceutical use, the hydrate state is important. Bromfenac sodium used in ophthalmic products is described as the sesquihydrate, with molecular weight 383.17 g/mol. (dailymed.nlm.nih.gov)
Bromfenac Sodium API can be supplied in suitable pharmaceutical-grade packaging according to customer requirements, product quantity and applicable pharmaceutical handling requirements.
Applicable documentation may include Certificate of Analysis (CoA), product specification, safety documentation, technical documentation and other quality documents according to product grade and customer requirements.
Store Bromfenac Sodium in tightly closed pharmaceutical-grade packaging and protect it from unsuitable environmental conditions. Follow the applicable product stability and storage specification.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers with Bromfenac Sodium API sourcing and commercial supply requirements.
Contact Swapnroop Drugs & Pharmaceuticals for Bromfenac Sodium availability, specifications, documentation, packaging and commercial supply information.
| 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 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |