Description

Flurbiprofen Impurity 15 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 engaged in method development, stability studies, and impurity profiling. The availability of a 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 conducting stability studies and degradation pathway analysis to determine shelf-life and storage conditions.
• Used in regulatory compliance and submission to agencies like the FDA and EMA, supporting impurity qualification reports.
• Valuable material for pharmacological and toxicological research to understand the impact of specific impurities.
• Serves as a system suitability test component in chromatographic analysis to ensure method robustness.

Basic Information

Product Name	Flurbiprofen Impurity 15
CAS No.	87657-78-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flurbiprofen Related Compound 15; Flurbiprofen EP Impurity G; Flurbiprofen USP Impurity; 2-Fluoro-α-methyl-[1,1'-biphenyl]-4-acetic Acid Impurity; (RS)-2-(2-Fluoro-4-biphenylyl)propionic Acid Impurity 15; Flurbiprofen Process Impurity; Flurbiprofen Degradant
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (USP, EP).

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. The container should be kept tightly sealed when not in use to prevent absorption of atmospheric moisture.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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