Abemaciclib Nitroso Impurity 54 NEW

Abemaciclib Nitroso Impurity 54

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E-mail: anna@molcoo.com.

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• Product Information

• Product Number: A066054

• English Name: Abemaciclib Nitroso Impurity 54

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

• CAS Number: None

• Molecular Formula: C₂₅H₂₇F₂N₉O

• Molecular Weight: 507.54

• Advantages

• As a nitroso impurity of Abemaciclib, this compound has the following advantages:
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• Well-defined and distinct structure: Contains fluorinated benzimidazole, pyrimidine, and nitrosopiperazinylmethylpyridine moieties, differing from abemaciclib by a nitroso (-NO) substituent on the piperazine ring. It can be accurately distinguished via HPLC and LC-MS, providing a specific marker for impurity detection;

• High stability and traceability: The conjugated structure of nitroso group and piperazine is stable under dark conditions. As a product of piperazine amino nitrosation during abemaciclib storage, it directly reflects oxidative deterioration, improving quality tracing accuracy;

• High detection sensitivity: Enhanced mass spectral response from difluorine electronegativity and nitroso polarity, combined with UV absorption of polycyclic conjugation (260-280nm), enables trace analysis via LC-MS (ppb level), compatible with nitrosopiperazine-containing heterocyclic drug impurity systems.

• Applications

• Pharmaceutical quality control: Used as an impurity reference standard to quantify Abemaciclib Nitroso Impurity 54 in APIs and formulations, ensuring residual nitroso impurities meet quality and regulatory requirements;

• Stability evaluation: Assessing oxidative stability of abemaciclib formulations under light/high temperature by monitoring impurity levels to guide storage conditions (e.g., light protection);

• Toxicological risk assessment: Contributing to nitroso impurity profiling for comprehensive safety evaluation, supporting regulatory submissions on genotoxicity concerns.

• Background Description

• Abemaciclib, a CDK4/6 inhibitor for breast cancer, features a piperazinylmethylpyridine side chain. During storage (especially with nitrites or oxidants), piperazine amino groups may undergo nitrosation to form 4-nitrosopiperazine derivatives like Abemaciclib Nitroso Impurity 54. Nitrosamines are potentially genotoxic, making this impurity’s control critical for abemaciclib quality assurance.

• Research Status

• Current research focuses on:
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• Analytical method validation: Developing UPLC-MS/MS assays with nitroso fragment (NO⁺) monitoring to achieve 0.1 ppb detection limits for trace impurity quantification;

• Nitrosation kinetics: Studying impurity formation under varying pH/redox conditions to identify key drivers of piperazine nitrosation in abemaciclib;

• Genotoxicity screening: Evaluating impurity mutagenicity via in vitro assays to establish scientifically based limits;

• Inhibition strategies: Developing nitrosation-blocking formulations (e.g., sulfite additives) to minimize impurity formation in abemaciclib products

This product is intended for laboratory use only!

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