Description

Bromfenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) belonging to the phenylacetic acid derivative class. This high-purity active pharmaceutical ingredient (API) is valued for its significant anti-inflammatory and analgesic properties, making it a critical component in advanced ophthalmic solutions. It is primarily utilized by pharmaceutical manufacturers and research institutions developing treatments for postoperative ocular inflammation and pain, such as following cataract surgery.

Application

• Ophthalmic Solutions: Primary use as the active ingredient in prescription eye drops for the treatment of postoperative inflammation and reduction of ocular pain.
• Pharmaceutical R&D: Serves as a key intermediate or reference standard in the research and development of novel NSAID formulations and delivery systems.
• Generic Drug Manufacturing: Essential for the production of generic versions of branded ophthalmic medications containing Bromfenac Sodium.
• Analytical Standards: Used as a high-purity certified reference material (CRM) in quality control laboratories for HPLC, UV, and other analytical method development and validation.

Basic Information

Item	Detail
Product Name	Bromfenac Sodium
CAS No.	91714-94-2
Molecular Formula	C15H11BrNNaO3
Molecular Weight	356.15 g/mol
Synonyms	Bromfenac Sodium Salt; 2-Amino-3-(4-bromobenzoyl)benzenacetic acid sodium salt; Y-4084; Sodium Bromfenac; Duprofen; (2-Amino-3-(4-bromobenzoyl)phenyl)acetic acid sodium salt; Bromfenac Na; Bromfenac Sodium Sesquihydrate (common form)
EINECS	Contact for details

Quality Control

Our Bromfenac Sodium is manufactured under strict quality management systems, targeting purity levels suitable for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing including HPLC for assay and related substances, residual solvent analysis, and identification by IR and NMR spectroscopy. A Certificate of Analysis (COA) detailing all test results against relevant specifications is provided with every shipment to ensure traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Impurity	≤ 0.5%
Water Content (KF)	≤ 5.0% (typically as sesquihydrate)
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.