Description

Flurbiprofen Impurity 17 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 involved in 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

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Flurbiprofen Impurity 17 in drug substance and drug product analysis.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring final product specifications are met.
• Stability Studies: Aids in forced degradation and long-term stability studies to identify and track impurity formation over the shelf-life of Flurbiprofen formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity understanding and control strategies to authorities like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research for impurity synthesis, characterization, and toxicological evaluation.

Basic Information

Product Name	Flurbiprofen Impurity 17
CAS No.	1206101-29-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flurbiprofen Related Compound 17; Flurbiprofen EP Impurity 17; Flurbiprofen USP Impurity 17; Flurbiprofen Process Impurity; 2-Fluoro-α-methyl-[1,1'-biphenyl]-4-acetic Acid Impurity; (RS)-2-(2-Fluoro-4-biphenylyl)propionic Acid Impurity 17
EINECS	Contact for details

Quality Control

Our Flurbiprofen Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assessment and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for APIs and excipients.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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