Product Number: F019052
English Name: Flurbiprofen Impurity 52
English Alias: 4,4'-dibromo-2,2'-difluoro-1,1'-biphenyl
CAS Number: 1515948-47-6
Molecular Formula: C₁₂H₆Br₂F₂
Molecular Weight: 347.98
As an impurity of flurbiprofen, Flurbiprofen Impurity 52 has a well-defined chemical structure and stable properties, and can be used as a standard reference for drug research, development, and quality control. Its high purity and precise structural characterization enable researchers to accurately analyze the by-product formation mechanism of bromination and fluorination reactions during flurbiprofen synthesis, optimize the production process, and reduce impurity generation. Meanwhile, as a specific impurity reference, it can significantly improve the accuracy and reliability of detection methods, ensuring strict control over the quality of flurbiprofen products.
Drug Development: During the research and development of flurbiprofen and its formulations, it is used as an impurity reference standard for identification and quantitative analysis, determining the impurity profile of drugs and evaluating the purity of active pharmaceutical ingredients and formulations;
Quality Control: As a standard substance, it is used to verify the sensitivity and accuracy of detection methods such as HPLC and LC-MS, ensuring that the content of this impurity during production meets pharmacopoeia and regulatory requirements;
Stability Studies: Research on the stability of this impurity under different environmental conditions (such as light, temperature, humidity) provides key data support for determining the storage conditions and shelf life of flurbiprofen.
Flurbiprofen is a non-steroidal anti-inflammatory drug commonly used to relieve pain, inflammation, and fever. During its synthesis, due to multiple halogenation reactions involved, various halogenated impurities, such as Flurbiprofen Impurity 52, are inevitably generated. The presence of such impurities may affect the safety and effectiveness of the drug. With the increasing requirements for drug quality in the pharmaceutical industry, strict control of flurbiprofen impurities has become an important part of ensuring drug quality. Therefore, the research and control of this impurity are of great significance in the quality control system of flurbiprofen.
Currently, research on Flurbiprofen Impurity 52 mainly focuses on the optimization of impurity detection methods, improvement of synthesis processes, and toxicological evaluations. Researchers are committed to developing more sensitive and efficient detection technologies, such as ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), to achieve trace detection of this impurity. At the same time, they deeply study its synthesis mechanism, reducing impurity generation by optimizing reaction conditions and raw material ratios. In addition, in vitro cell experiments and animal models are used to evaluate the potential toxicity of this impurity, providing a scientific basis for formulating reasonable impurity limit standards and ensuring the safety of flurbiprofen drugs
China
