Description

Flurbiprofen Impurity B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Flurbiprofen. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Flurbiprofen API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability testing protocols.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in pharmaceutical R&D to study the metabolic pathways, degradation mechanisms, and synthesis impurities of Flurbiprofen.

Basic Information

Product Name	Flurbiprofen Impurity B
CAS No.	1797883-74-9
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	2-Fluoro-α-methyl-[1,1'-biphenyl]-4-acetic Acid Impurity B; Flurbiprofen Related Compound B; 2-(2-Fluoro-4-biphenylyl)propionic Acid Impurity; 2-(3-Fluoro-4-phenylphenyl)propanoic Acid Impurity; Flurbiprofen EP Impurity B; Flurbiprofen USP Impurity B; Flurbiprofen Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with in-house specifications aligned with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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