Exatecan Impurity

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

• Product Information

• Product Number: E068003

• English Name: Exatecan Impurity 3

• English Alias: N-(8-amino-6-fluoro-5-methyl-1-oxo-1,2,3,4-tetrahydronaphthalen-2-yl)acetamide

• CAS Number: 182182-31-6

• Molecular Formula: C13H15FN2O2

• Molecular Weight: 250.27

• Advantages: As a reference standard for Exatecan Impurity 3, it has a clear chemical structure confirmed by multiple analytical methods, with a purity of ≥98.5% (HPLC). Under low-temperature (2 - 8°C), light-protected, and dry storage conditions, it exhibits stable chemical properties and high batch-to-batch quality consistency. It can be precisely used for the qualitative and quantitative analysis of Impurity 3 in exatecan bulk drugs and formulations, providing a reliable reference for drug quality control and meeting the strict requirements of drug research, development, production, and quality supervision.

• Applications:

• Quality Testing: Used to establish and optimize the detection methods for Impurity 3 in exatecan, such as high-performance liquid chromatography (HPLC) and liquid chromatography - mass spectrometry (LC - MS). By accurately determining the content of Impurity 3, the quality of drugs can be evaluated to meet relevant standards and regulatory requirements.

• Process Optimization: During the production of exatecan, monitor the content of Impurity 3 in real time. Analyze its generation under different reaction conditions, optimize synthesis process parameters, such as reaction temperature, time, and raw material ratio, to reduce impurity production and improve the purity and quality of bulk drugs.

• Stability Studies: In drug stability tests (accelerated tests, long-term tests), track the changes in the content of Impurity 3, analyze its impact on drug stability, and provide data support for determining the shelf life and storage conditions of drugs.

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

• Background Description: Exatecan is a topoisomerase I inhibitor used in cancer treatment. Due to the complexity of reactions and the properties of raw materials and intermediates during its synthesis, various impurities are inevitably generated. As a specific impurity of exatecan, the presence of Impurity 3 may affect the safety and effectiveness of the drug. With the continuous improvement of drug quality standards and increasingly strict regulatory requirements, strict control of Impurity 3 in exatecan has become an important part of ensuring drug quality and patient medication safety.

• Research Status:

• Detection Technology: Currently, the HPLC - UV method is mainly used to detect Exatecan Impurity 3. By optimizing conditions such as the type of chromatographic column, the composition of the mobile phase, and the detection wavelength, effective separation and accurate quantification of impurities can be achieved, with a detection limit of up to 0.05%. The application of LC - MS technology has further improved the sensitivity and accuracy of detection, enabling more precise identification of impurity structures.

• Formation Mechanism: Research shows that Impurity 3 may originate from the acetylation side reaction of key intermediates during the synthesis of exatecan, or from reactions involving impurities in the raw materials. Through in-depth analysis of the synthesis route, researchers have clarified the key factors affecting its generation, providing a theoretical basis for process improvement.

• Safety Evaluation: The toxicological research on Impurity 3 is gradually being carried out. Preliminary experimental data show that this impurity may affect cell activity at a certain concentration. Therefore, strict limits have been set for it in drug quality standards. In the future, further in-depth research on its toxicity mechanism and safety threshold is needed to develop more scientific and reasonable impurity control strategies.

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




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