Abemaciclib Nitroso Impurity 43 NEW

Abemaciclib Nitroso Impurity 43

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E-mail: anna@molcoo.com.

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• Product Information

• Product Number: A066043

• English Name: Abemaciclib Impurity 43

• English Alias: 5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)-N-(5-(piperazin-1-ylmethyl)pyridin-2-yl)pyrimidin-2-amine

• CAS Number: 1231930-57-6

• Molecular Formula: C₂₅H₂₈F₂N₈

• Molecular Weight: 478.54

• Advantages

• As an impurity of Abemaciclib, this compound has the following advantages:
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• Well-defined and distinct structure: Contains fluorinated benzimidazole, pyrimidine, and piperazinylmethylpyridine moieties, with structural differences from abemaciclib in substituent positions or types. It can be accurately identified by techniques such as HPLC and LC-MS, providing a specific marker for impurity detection;

• High stability and traceability: The conjugated system of polycyclic aromatic structures and multiple amino groups is highly stable. As a by-product of incomplete coupling reactions in abemaciclib synthesis, it directly reflects the efficiency of key steps, improving process tracing accuracy;

• High detection sensitivity: The electronegativity of fluorine atoms and strong UV absorption (260-280nm) of the polycyclic conjugated system, combined with characteristic mass response (m/z 479 [M+H]⁺), enable trace analysis via LC-MS, compatible with pyrimidine-based CDK4/6 inhibitor detection systems.

• Applications

• Pharmaceutical quality control: Used as an impurity reference standard to identify and quantify Abemaciclib Impurity 43 in abemaciclib APIs and formulations, ensuring residual impurities meet quality standards;

• Synthesis process optimization: Optimizing coupling reaction conditions (e.g., catalyst selection, temperature) by monitoring impurity content to enhance target product selectivity and reduce by-product formation;

• Impurity profile enrichment: Contributing to the completeness of abemaciclib’s impurity profile, providing key data for comprehensive purity assessment and supporting drug registration applications.

• Background Description

• Abemaciclib, a CDK4/6 inhibitor for hormone receptor-positive breast cancer, features polycyclic heterocyclic systems including benzimidazole and pyrimidine. During synthesis, incomplete coupling of benzimidazole with pyrimidine or piperazine methylation may generate structurally similar impurities like Abemaciclib Impurity 43. The presence of such impurities can affect drug purity and stability, making their control critical for abemaciclib quality assurance.

• Research Status

• Current research focuses on:
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• Analytical method validation: Developing UPLC-MS/MS assays for simultaneous quantification of abemaciclib and its impurity 43, achieving detection limits as low as 0.1 ppb for pharmaceutical analysis;

• Synthetic efficiency enhancement: Designing novel coupling strategies to minimize impurity formation by improving regioselectivity in benzimidazole-pyrimidine conjugation;

• Toxicological screening: Evaluating potential cytotoxicity of the impurity via in vitro cell assays to establish scientifically based impurity limits;

• Formulation compatibility studies: Assessing interactions between the impurity and excipients to ensure stability of abemaciclib formulations during shelf life.

This product is intended for laboratory use only!

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