Description

Bromfenac Sodium Impurity 4 is a specified impurity and analytical reference standard used in the quality control of the active pharmaceutical ingredient (API) Bromfenac Sodium. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Bromfenac Sodium API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating assay methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and data for health authority submissions.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in Bromfenac Sodium under various stress conditions.
• Pharmaceutical Research (R&D): Used in synthetic route research, impurity profiling, and process chemistry to understand and control impurity formation.
• Quality Assurance/Quality Control (QA/QC): A critical component for in-process testing, release testing, and batch-to-batch consistency verification.

Basic Information

Product Name	Bromfenac Sodium Impurity 4
CAS No.	91714-58-8
Molecular Formula	C15H12BrNO3Na
Molecular Weight	357.16 g/mol
Synonyms	2-Amino-3-(4-bromobenzoyl)benzenesodium acetate; Sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate; Bromfenac Impurity D; Bromfenac Related Compound D; Bromfenac Sodium EP Impurity D; Bromfenac Sodium USP Impurity D; 4-Bromo-α-oxo-N-(2-carboxyphenyl)benzenesodium ethanamide
EINECS	Contact for details

Quality Control

Our Bromfenac Sodium Impurity 4 is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with in-house specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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