Description

Flurbiprofen Impurity 5 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 regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Flurbiprofen API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Flurbiprofen formulations under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to understand the synthesis pathways, degradation routes, and metabolic fate of Flurbiprofen.

Basic Information

Product Name	Flurbiprofen Impurity 5
CAS No.	124635-84-3
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	2-Fluoro-α-methyl-[1,1'-biphenyl]-4-acetic Acid Impurity 5; Flurbiprofen Related Compound 5; 2-(2-Fluoro-4-biphenylyl)propionic Acid Impurity; 2-(3-Fluoro-4-phenylphenyl)propanoic Acid Impurity; Flurbiprofen EP Impurity B; Flurbiprofen USP Related Compound; (RS)-2-(2-Fluoro-4-phenylbiphenyl-4-yl)propanoic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity 5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC, and NMR, to ensure identity, purity, and traceability conform to 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) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.