Description

Flurbiprofen Impurity 14 (Menthyl Ester) is a high-purity reference standard and impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Flurbiprofen by serving as a key marker in analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for precise impurity profiling, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Flurbiprofen and its related substances.
• Impurity Profiling & Control: Essential for identifying, monitoring, and controlling this specific impurity during Flurbiprofen API (Active Pharmaceutical Ingredient) manufacturing to meet ICH Q3A/B guidelines.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, and GC methods for impurity separation and detection.
• Stability Studies: Employed in forced degradation and long-term stability testing to understand the degradation pathways of Flurbiprofen formulations.
• Regulatory Compliance & Filing: Used to generate data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity understanding and control.
• Quality Control (QC) Testing: Acts as a system suitability standard in routine QC testing of Flurbiprofen raw materials and finished drug products.

Basic Information

Product Name	Flurbiprofen Impurity 14 (Menthyl Ester)
CAS No.	908559-44-4
Molecular Formula	C24H28O3
Molecular Weight	364.48 g/mol
Synonyms	Flurbiprofen Menthyl Ester; Flurbiprofen Related Compound 14; 2-Fluoro-α-methyl-[1,1'-biphenyl]-4-acetic acid, 1,2,3,4,5,6,7,8-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-naphthalenyl ester; (1R,2S,5R)-2-Isopropyl-5-methylcyclohexyl 2-(2-fluorobiphenyl-4-yl)propanoate; Flurbiprofen Impurity F; Menthol ester of Flurbiprofen
EINECS	Contact for details

Quality Control

Every batch of Flurbiprofen Impurity 14 (Menthyl Ester) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity quantification via advanced chromatographic techniques. Certificates of Analysis (COA) containing detailed batch-specific results are available upon request, supporting your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.