Description

Flurbiprofen Impurity 6 is a high-purity chemical reference standard used in the analytical profiling of the non-steroidal anti-inflammatory drug (NSAID) Flurbiprofen. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by serving as a benchmark for identification and quantification during quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Flurbiprofen Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately detect and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation of degradation products in Flurbiprofen formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files and investigational new drug applications.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Flurbiprofen.
• Calibration & System Suitability: Serves as a calibrant to ensure the precision and accuracy of analytical instrumentation.

Basic Information

Product Name	Flurbiprofen Impurity 6
CAS No.	124635-86-5
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	Flurbiprofen Related Compound 6; 2-Fluoro-α-methyl-4-biphenylacetic Acid Impurity 6; 2-(3-Fluoro-4-phenylphenyl)propanoic Acid Impurity; Flurbiprofen EP Impurity F; Flurbiprofen USP Related Compound F; [1,1'-Biphenyl]-4-acetic acid, 2-fluoro-α-methyl- (related impurity)
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including potential alignment with pharmacopeial guidelines (e.g., USP, EP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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