Description

Bromfenac Sodium Impurity E is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Bromfenac Sodium, identified by the CAS registry number 61112-01-4. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and contract research organization (CRO) sectors for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Bromfenac Sodium and its related substances.
• Impurity Profiling and Identification: Essential for identifying, characterizing, and monitoring Impurity E during drug substance and drug product stability studies.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Batch Release: Employed in routine QC testing to ensure drug batches meet stringent purity specifications set by pharmacopeias (USP, EP).
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control and understanding of the drug's chemistry.
• Stability Indicating Method: Helps establish the degradation pathways of Bromfenac Sodium under various stress conditions (e.g., heat, light, humidity).

Basic Information

Product Name	Bromfenac Sodium Impurity E
CAS No.	61112-01-4
Molecular Formula	C15H12BrNO3
Molecular Weight	334.17 g/mol
Synonyms	2-Amino-3-(4-bromobenzoyl)benzoic Acid; Bromfenac Impurity E; Bromfenac Related Compound E; 2-Amino-3-(4-bromobenzoyl)benzoic Acid Impurity; 2-(2-Amino-3-benzoylphenyl)acetic Acid Impurity (Bromfenac); 3-Benzoyl-2-aminobenzoic Acid Derivative; [1,1'-Biphenyl]-2-carboxylic Acid, 2-Amino-5-bromo-α-oxo-
EINECS	Contact for details

Quality Control

Every batch of Bromfenac Sodium Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, purity, and related substances is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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