Description

Bromfenac Sodium Impurity 7 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Bromfenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical validation and routine testing of Bromfenac Sodium active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance: Used in-house by QC laboratories to establish impurity profiles, set specifications, and ensure batch-to-batch consistency in compliance with ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for impurity identification as required by ICH Q3A(R2) and Q3B(R2).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to determine product shelf-life.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and metabolism of Bromfenac Sodium.

Basic Information

Product Name	Bromfenac Sodium Impurity 7
CAS No.	91714-48-6
Molecular Formula	C15H11BrNNaO3
Molecular Weight	356.15 g/mol
Synonyms	2-Amino-3-(4-bromobenzoyl)benzenesodium acetate; Sodium 2-(2-amino-3-benzoylphenyl)acetate; Bromfenac Impurity 7; Bromfenac Sodium Related Compound 7; Bromfenac EP Impurity G; Bromfenac Sodium impurity; 91714-48-6
EINECS	Contact for details

Quality Control

Every batch of Bromfenac Sodium Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH regulatory 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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.