Description

Flurbiprofen Impurity 16 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Flurbiprofen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Flurbiprofen API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Flurbiprofen Impurity 16 in active pharmaceutical ingredients (API) and drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Used in routine QC testing to ensure Flurbiprofen batches comply with pharmacopeial (USP, EP, BP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity, acid/base).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to establish impurity thresholds and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing Flurbiprofen synthesis pathways to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Flurbiprofen Impurity 16
CAS No.	74648-00-3
Molecular Formula	C15H13FO2
Molecular Weight	244.26 g/mol
Synonyms	1,1'-Biphenyl, 2-fluoro-α-methyl-4-(1-methylethyl)-; 2-Fluoro-α-methyl-4-(1-methylethyl)-1,1'-biphenyl; Flurbiprofen Related Compound; Flurbiprofen Degradation Product; Flurbiprofen Process Impurity; (RS)-2-(2-Fluoro-4-isopropylbiphenyl-4-yl)propanoic acid impurity; Flurbiprofen Impurity F (may vary by pharmacopeia)
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using validated analytical methods (e.g., HPLC, GC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture. For long-term storage, consider storing under an 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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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