Abemaciclib Impurity
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
Product Information
Product Number: A066049
English Name: Abemaciclib Impurity 49
English Alias: 5-(piperazin-1-ylmethyl)pyridin-2-amine
CAS Number: 1178566-47-6
Molecular Formula: C10H16N4
Molecular Weight: 192.26
Advantages: As a reference standard for Abemaciclib Impurity 49, it has a well-defined chemical structure and high purity, with strict quality control and structural confirmation. It exhibits good stability and can maintain consistent properties under various storage conditions. Its precise purity and reliable batch consistency provide an efficient and accurate reference for impurity detection in abemaciclib bulk drugs and formulations, ensuring the repeatability and credibility of detection results and facilitating the improvement of drug quality control systems.
Applications: It is mainly used in the quality research, impurity analysis, and production quality control of abemaciclib. It can be used to establish and validate detection methods such as high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) to accurately determine the content of this impurity in drugs. In the R&D stage, it helps analyze the source and formation mechanism of impurities to optimize the synthesis process and reduce impurity generation. In the production process, it monitors the content of Impurity 49 in real time to ensure that drug quality meets regulatory standards. It can also be used to evaluate the changes of impurities in abemaciclib during storage and transportation, providing data support for drug stability research.
Background Description: Abemaciclib is a CDK4/6 inhibitor used in the treatment of breast cancer and other cancers. During its research, development, and production, the presence of impurities may affect the safety and effectiveness of the drug. Strict control of impurity content is a key link in ensuring drug quality. As one of the potential impurities of abemaciclib, in-depth research and precise control of Abemaciclib Impurity 49 help comprehensively understand the impurity profile of the drug, meet international regulatory requirements, and ensure the safety of patient medication.
Research Status: Current research on Abemaciclib Impurity 49 focuses on the optimization of impurity detection techniques and the analysis of generation mechanisms. Researchers continuously improve the sensitivity and accuracy of impurity detection by optimizing chromatographic separation conditions and using high-sensitivity mass spectrometry, achieving precise quantification of trace impurities. At the same time, combined with the synthesis route of abemaciclib, the possible formation pathways of this impurity are analyzed, and measures such as adjusting reaction conditions and optimizing purification processes are taken to reduce its production. In addition, studies on the impact of this impurity on the efficacy and safety of abemaciclib are gradually being carried out to provide a scientific basis for formulating reasonable impurity limit standards.
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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