Description

Flurbiprofen Related Impurity 2 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 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

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Flurbiprofen API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during API synthesis and purification.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved synthetic routes with lower impurity profiles.

Basic Information

Product Name	Flurbiprofen Related Impurity 2
CAS No.	42771-82-4
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	2-Fluoro-α-methyl-4-biphenylacetic Acid Impurity; Flurbiprofen Impurity B; 2-(2-Fluoro-4-biphenylyl)propanoic Acid Related Substance; [1,1'-Biphenyl]-4-acetic acid, 2-fluoro-α-methyl-; Flurbiprofen EP Impurity B; Flurbiprofen USP Related Compound; Flurbiprofen Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Related Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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
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.