Description

Bromfenac Impurity 13 is a designated impurity standard used in the analytical profiling and quality control of the non-steroidal anti-inflammatory drug (NSAID) Bromfenac. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Bromfenac Impurity 13 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Used in routine QC testing to ensure Bromfenac drug substance and drug product batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing characterized impurity data required by agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Research & Development: Used in R&D to understand the degradation pathways of Bromfenac and to synthesize purer API batches.

Basic Information

Product Name	Bromfenac Impurity 13
CAS No.	1279501-08-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bromfenac Related Compound 13; Bromfenac EP Impurity J; Bromfenac USP Impurity; 2-Amino-3-(4-bromobenzoyl)benzenesulfonamide (probable structure); Bromfenac Degradation Product; Bromfenac Process Impurity; Bromfenac Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Bromfenac Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmacopeial standards. 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. This material is typically hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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