N-Demethyl Clindamycin NEW

N-Demethyl Clindamycin;22431-45-4

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

• Product Number: C041057

• English Name: N-Demethyl Clindamycin

• English Alias: (2S,4R)-N-((1S,2S)-2-chloro-1-((2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(methylthio)tetrahydro-2H-pyran-2-yl)propyl)-4-propylpyrrolidine-2-carboxamide

• CAS Number: 22431-45-4

• Molecular Formula: C₁₇H₃₁ClN₂O₅S

• Molecular Weight: 410.96

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• As a demethylated impurity reference standard for clindamycin, this compound has the following advantages:
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• Well-defined and Stable Structure: With a clear chemical structure and good stability, it is convenient to analyze the by-product formation mechanism of the methylation reaction during clindamycin synthesis, and optimize the production process to reduce impurity generation.

• Accurate Detection Standard: The structural features with multiple functional groups such as chlorine atoms, hydroxyl groups, and thioether bonds can provide an accurate standard for detection methods such as HPLC and LC-MS, significantly improving the separation and quantification accuracy of impurities related to clindamycin.

• Facilitating Quality Research: It helps to deeply study the influence of the demethylated structure on drug stability, efficacy, and toxicological properties, providing a scientific basis for impurity control strategies and ensuring drug quality.

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• Drug Development: During the research and development of clindamycin and its formulations, it is used as an impurity reference standard to identify and quantify N-Demethyl Clindamycin, accurately evaluating the purity of APIs and formulations.

• Quality Control: As a standard substance, it is used to verify the sensitivity and specificity of detection methods such as HPLC and LC-MS, ensuring that the content of this impurity during production meets pharmacopoeia and relevant regulatory requirements.

• Stability Studies: Investigating the degradation behavior of this impurity under different environmental conditions such as light, high temperature, and high humidity, evaluating its impact on the stability of clindamycin formulations, and providing data support for formulating reasonable storage conditions and shelf life.

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• Clindamycin is a lincosamide antibiotic widely used in the treatment of various bacterial infectious diseases. During its synthesis, due to the complex reaction steps involving multiple functional group modifications and structural constructions, if the methylation reaction is incomplete or the reaction conditions are not properly controlled, demethylated impurities such as N-Demethyl Clindamycin are likely to be generated. The presence of such impurities may affect drug safety, effectiveness, and bioavailability. Therefore, the research and control of clindamycin impurities are key links to ensure drug quality and clinical medication safety.

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• Currently, research on N-Demethyl Clindamycin mainly focuses on the following aspects:
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• Detection Method Optimization: Using advanced technologies such as ultra-high-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) and high-resolution mass spectrometry (HRMS) to develop highly sensitive and selective detection methods for trace detection of this impurity.

• Synthesis Process Improvement: Deeply studying the formation pathway of this impurity, and developing synthesis processes to reduce impurity generation by optimizing reaction conditions (such as reaction temperature, time, catalyst selection) and raw material ratios.

• Toxicological Evaluation: Evaluating the potential toxicity of this impurity through in vitro cytotoxicity experiments and animal models, providing data support for scientifically formulating reasonable impurity limit standards.

• Stability Research: Systematically studying the stability of this impurity under the influence of different environmental factors, analyzing its impact on the quality of clindamycin formulations, and further improving the drug quality control system

This product is intended for laboratory use only!

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