Description

Bromfenac Impurity 34 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Bromfenac. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Bromfenac Impurity 34 in API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Bromfenac API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Bromfenac.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the Bromfenac API.

Basic Information

Product Name	Bromfenac Impurity 34
CAS No.	91713-90-5
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 of Bromfenac; Bromfenac Related Compound 34; Bromfenac EP Impurity 34; Bromfenac USP Impurity 34; 3-(4-Bromobenzoyl)-2-aminobenzoic acid; 2-Amino-3-(p-bromobenzoyl)benzoic acid
EINECS	Contact for details

Quality Control

Our Bromfenac Impurity 34 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic (HPLC/UPLC) and spectroscopic (IR, NMR, MS) techniques. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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