Description

Flurbiprofen Impurity 8 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Flurbiprofen. This compound is of critical importance in the pharmaceutical industry for analytical research, method development, and quality control processes. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development and quality assurance of Flurbiprofen-based drug products.

Application

• Pharmaceutical Reference Standard: Serves 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: Used as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Essential for preparing impurity profiles and supporting documentation required for drug master files (DMFs) and regulatory filings with agencies like the FDA and EMA.
• Research & Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Flurbiprofen.

Basic Information

Product Name	Flurbiprofen Impurity 8
CAS No.	91503-88-7
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	2-Fluoro-α-methyl-4-biphenylacetic Acid Impurity 8; 1,1'-Biphenyl, 2-fluoro-4-(1-hydroxyethyl)-; 2-Fluoro-4-(1-hydroxyethyl)-1,1'-biphenyl; Flurbiprofen Alcohol; Flurbiprofen Related Compound 8; Flurbiprofen EP Impurity B; Flurbiprofen Hydroxy Impurity
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. 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, typically between 15-25°C, in a dry environment. This material is light-sensitive and should be handled accordingly 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)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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