Flurbiprofen Impurity;61467-10-5

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• Product Information

• Product Number: F019054

• English Name: Flurbiprofen Impurity 54

• English Alias: 2-(2-fluoro-[1,1'-biphenyl]-4-yl)-N,N-dimethylpropanamide

• CAS Number: 61467-10-5

• Molecular Formula: C??H??FNO

• Molecular Weight: 271.33

• Advantages

• As an impurity reference standard for flurbiprofen, this compound has the following advantages:
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• Well-defined structure and high stability: Precise biphenyl fluorination and amide structure, enabling analysis of by-product formation mechanisms during flurbiprofen synthesis, such as aryl substitution and amidation reactions, to optimize processes for impurity control;

• Fluorinated biphenyl structure standard substance: Characteristic structure with fluorine atom and biphenyl skeleton, providing an accurate standard for HPLC, LC-MS, and other detection methods to improve separation and quantification accuracy of fluorinated impurities;

• Facilitating impurity traceability research: Analyzing the formation pathway of this impurity can trace raw material residues or reaction condition deviations in flurbiprofen synthesis, providing a basis for process optimization.

• Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity 54 in flurbiprofen and its formulations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity and specificity of detection methods (e.g., HPLC, LC-MS), ensuring impurity content meets pharmacopoeia requirements during production;

• Stability Studies: Investigating the degradation behavior of this impurity under light, high temperature, and high humidity conditions to evaluate its impact on flurbiprofen formulation stability.

• Background Description

• Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) used for relieving pain and inflammation. During its synthesis, incomplete arylation reactions or improper selection of amidation reagents easily generate impurities containing N,N-dimethylamide structures. Such impurities may affect drug safety and effectiveness, making research on flurbiprofen impurities a key part of drug quality control.

• Research Status

• Current research focuses on:
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• Detection method optimization: Using ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) technology, optimizing separation conditions by leveraging the electronegativity of fluorine atoms to achieve trace detection;

• Synthesis process improvement: Reducing the generation of biphenyl substitution by-products by optimizing the catalyst (such as boron trifluoride) and reaction temperature of fluorination reactions;

• Toxicological evaluation: Evaluating the potential impact of this impurity on gastrointestinal mucosal cells through in vitro cytotoxicity experiments;

• Crystal form research: Analyzing the impact of impurity crystal form on the stability of flurbiprofen tablets during tableting to improve the quality control system

This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com