Description

Bromfenac Sodium Impurity Isomer is a designated process-related impurity and stereoisomer of the non-steroidal anti-inflammatory drug (NSAID) Bromfenac Sodium. This high-purity reference standard is critical for analytical method development, validation, and ensuring the quality and safety of the active pharmaceutical ingredient (API). It is an essential material for pharmaceutical R&D and quality control laboratories focused on impurity profiling and regulatory compliance for ophthalmic and other formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Bromfenac Sodium API and finished drug products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Assurance: Used in routine batch testing to monitor and control the levels of this specific isomer during API synthesis and purification processes.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data required under ICH Q3A(R2) and Q3B(R2).
• Stability Studies: Employed to track the formation or increase of this impurity under various stress conditions (heat, light, humidity) as part of forced degradation studies.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this isomer, improving overall yield and purity.

Basic Information

Product Name	Bromfenac Sodium Impurity Isomer
CAS No.	76049-81-5
Molecular Formula	C15H11BrNNaO3
Molecular Weight	356.15 g/mol
Synonyms	Bromfenac Sodium Isomer; Bromfenac Related Compound; 2-Amino-3-(4-bromobenzoyl)benzenesodium acetate isomer; Sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate isomer; Y-8004 Sodium Salt Impurity; Bromfenac EP Impurity; Bromfenac USP Impurity
EINECS	Contact for details

Quality Control

Every batch of our Bromfenac Sodium Impurity Isomer is manufactured and handled in a controlled environment. It undergoes rigorous analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. Our quality system ensures compliance with relevant standards for pharmaceutical impurities. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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