Description

Bromfenac Impurity 45 is a designated reference standard used in the analytical profiling and quality control of the non-steroidal anti-inflammatory drug (NSAID) Bromfenac. 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 method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Bromfenac API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor degradation pathways.
• Quality Control & Assurance: Employed in routine QC testing to ensure batches of Bromfenac meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the drug's degradation profile.
• Research & Development: Utilized in pharmaceutical R&D for impurity isolation, characterization, and toxicological studies.

Basic Information

Product Name	Bromfenac Impurity 45
CAS No.	91714-49-7
Molecular Formula	C15H12BrNO3
Molecular Weight	334.17 g/mol
Synonyms	2-Amino-3-(4-bromobenzoyl)benzoic acid; 2-Amino-3-(4-bromobenzoyl)benzoic Acid Impurity; Bromfenac Impurity J; Bromfenac Related Compound J; Bromfenac EP Impurity J; Bromfenac USP Impurity J; 3-(4-Bromobenzoyl)-2-aminobenzoic acid
EINECS	Contact for details

Quality Control

Our Bromfenac Impurity 45 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3B(R2) guidelines and pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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