Description

Flurbiprofen Impurity 56 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. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Flurbiprofen API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control laboratories.
• Essential for impurity profiling and stability studies to meet ICH guidelines and regulatory submission requirements (e.g., FDA, EMA).
• Used in pharmacopoeial testing to verify compliance with USP, EP, or other pharmacopoeia monographs for Flurbiprofen.
• Valuable material for research and development into the degradation pathways and metabolism of Flurbiprofen.
• Serves as a calibration standard in mass spectrometry and other spectroscopic techniques for accurate impurity detection.

Basic Information

Product Name	Flurbiprofen Impurity 56
CAS No.	866235-89-4
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	2-Fluoro-α-methyl-4-biphenylacetic Acid Impurity 56; Flurbiprofen Related Compound 56; [1,1'-Biphenyl]-4-acetic acid, 2-fluoro-α-methyl- (Impurity); Flurbiprofen EP Impurity I; Flurbiprofen Process Impurity; Flurbiprofen Degradant; 2-(2-Fluoro-4-phenylphenyl)propanoic acid (Impurity)
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity 56 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and precise identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profiles. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 stability, storage at 2-8°C is recommended. Keep the container tightly sealed in a cool, well-ventilated place away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Assay	95.0% - 105.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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