Description

Flurbiprofen Related Impurity 1 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker for ensuring the quality, safety, and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Flurbiprofen. It is essential for analytical chemists and quality control laboratories in the pharmaceutical industry who require precise standards for method development, validation, and regulatory compliance. The use of this well-characterized impurity supports robust impurity profiling and helps manufacturers meet stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Flurbiprofen Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against established specifications, ensuring product safety.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug approval.
• Stability Studies: Employed to track the formation of degradation products in Flurbiprofen formulations under various stress conditions (ICH Q1A).
• Pharmacopeial Testing: Used to verify compliance with impurity limits specified in pharmacopeias such as USP, EP, or BP.
• Research & Development: Aids in synthetic route optimization and process chemistry by identifying and controlling process-related impurities.

Basic Information

Item	Detail
Product Name	Flurbiprofen Related Impurity 1
CAS No.	42771-81-3
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	2-Fluoro-α-methyl-4-biphenylacetic acid; 2-(2-Fluoro-4-biphenylyl)propionic acid; Flurbiprofen Impurity A; Flurbiprofen EP Impurity A; Flurbiprofen USP Related Compound A; (±)-2-(2-Fluoro-4-phenylphenyl)propanoic acid; 4-Biphenylacetic acid, 2-fluoro-α-methyl-; UNII-2JZ0L1Q45C
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Related Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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