Description

Bromfenac Sodium Impurity C is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Bromfenac Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Bromfenac Sodium API and its finished pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Bromfenac Sodium Active Pharmaceutical Ingredient (API).
• Analytical Method Development: Crucial for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., Drug Master Files, CMC sections) by providing impurity characterization data.
• Research & Development: Aids in synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Bromfenac Sodium Impurity C
CAS No.	70803-94-0
Molecular Formula	C15H11BrNNaO3
Molecular Weight	356.15 g/mol
Synonyms	2-Amino-3-(4-bromobenzoyl)benzenesodium acetate; Sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate; Bromfenac Impurity C; Bromfenac Sodium Related Compound C; Bromfenac EP Impurity C; Bromfenac USP Impurity C; (2-Amino-3-(4-bromobenzoyl)phenyl)acetic acid sodium salt
EINECS	Contact for details

Quality Control

Every batch of Bromfenac Sodium Impurity C is manufactured and controlled under a strict quality management system. Comprehensive analytical testing is performed to ensure identity, purity, and consistency, aligning with current industry and regulatory expectations, including ICH guidelines. A detailed Certificate of Analysis (COA) providing batch-specific results for identity (IR, HPLC), assay (HPLC), and related substances is supplied with each product.

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 material 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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