Exatecan Impurity

NOTE！

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery! 

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  WhatsAPP: +86 17320513646
  E-mail: anna@molcoo.com

• Product Information

  • Product Number: E068005

  • English Name: Exatecan Impurity 5

  • English Alias: N-((9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-1,2,3,9,10,12,13,15-octahydrobenzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl)acetamide

  • CAS Number: 2290562-59-1

  • Molecular Formula: C26H24FN3O5

  • Molecular Weight: 477.48

• Advantages: As a reference standard for Exatecan Impurity 5, its chemical structure is accurately confirmed by multiple methods including NMR, MS, and X-ray single-crystal diffraction, with a purity as high as ≥99.0% (HPLC). Under low-temperature (2 - 8°C), light-protected, and dry storage conditions, it exhibits stable properties with a shelf life of up to 24 months and excellent batch-to-batch quality consistency. It is suitable for highly sensitive and precise impurity analysis, providing a reliable and stable reference substance for the quality control of exatecan.

• Applications:

  • Development of Impurity Detection Methods: Used to establish and optimize the detection methods for Impurity 5 in exatecan, such as high-performance liquid chromatography (HPLC) and liquid chromatography - mass spectrometry (LC - MS). By determining appropriate detection conditions and parameters, precise quantitative analysis of this impurity can be achieved, with a detection limit as low as 0.01%.

  • Quality Monitoring in the Production Process: During the production of exatecan, monitor the content of Impurity 5 in real time. Adjust the synthesis process parameters, such as reaction temperature, time, and raw material ratio, in a timely manner according to the detection results, effectively reducing the generation of impurities, ensuring stable product quality, and meeting relevant quality standards and regulatory requirements.

  • Drug Stability Research: In drug stability tests (accelerated tests, long-term tests), track the trend of Impurity 5 content changes over time and in different environments, evaluate the quality stability of drugs under various storage conditions, and provide detailed data support for determining the shelf life and storage conditions of drugs.

  • Ensuring Regulatory Compliance: Assist pharmaceutical companies in meeting the requirements of domestic and international drug regulatory agencies (such as FDA, EMA, NMPA) for drug impurity limits. Provide accurate and reliable impurity detection data during the drug registration and marketing application process to ensure that products meet regulatory standards and pass the review smoothly.

• Background Description: Exatecan is a topoisomerase I inhibitor used for cancer treatment. Due to the complexity of its multi-step synthesis involving various raw materials, a variety of impurities are inevitably generated. As a specific impurity of exatecan, the presence of Impurity 5 may affect the drug's efficacy and safety. With the continuous improvement of drug quality standards and the increasingly strict global drug regulation, strict control and in-depth research on Impurity 5 in exatecan have become crucial for ensuring drug quality and patient safety, and are of great significance for improving the quality standard system of exatecan.

• Research Status:

  • Detection Technology: Currently, the mainstream detection technology is LC - MS/MS. By optimizing the type of chromatographic column (such as C18 reversed-phase column with 1.7μm particle size), the composition of the mobile phase (acetonitrile - water system with ammonium formate buffer), and mass spectrometry parameters (electrospray ionization source, multiple reaction monitoring mode), highly sensitive detection of Impurity 5 can be achieved, with a detection limit reaching 0.01 ng/mL, significantly improving the accuracy and efficiency of impurity analysis.

  • Formation Mechanism: Research shows that Impurity 5 may originate from abnormal acetylation reactions of key intermediates during the synthesis of exatecan, or from the participation of trace impurities in raw materials in reactions under specific conditions. Through detailed analysis of the synthesis route and simulation experiments, researchers have gradually clarified the key factors affecting the generation of Impurity 5, such as excessively high reaction temperature, too long reaction time, and residual catalysts, providing a theoretical basis for optimizing the synthesis process.

  • Safety Evaluation: The toxicological research on Impurity 5 is still ongoing. Preliminary in vitro cell experiments show that high concentrations of Impurity 5 may interfere with the proliferation and apoptosis of tumor cells, indicating its potential biological activity. Currently, strict limits have been set for it in drug quality standards, but further animal experiments and clinical studies are still needed to deeply explore its toxicity mechanism and safety threshold, so as to develop more scientific and reasonable impurity control strategies.

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