Nilotinib Impurity 32(Nitrate)；2763779-41-3

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E-mail: anna@molcoo.com.

• Product Information

• Product Number: N019032A

• English Name: Nilotinib Impurity 32(Nitrate)

• English Alias: ethyl 3-guanidino-4-methylbenzoate nitrate

• CAS Number: 641569-96-2

• Molecular Formula: C??H??N?O?·HNO?

• Molecular Weight: 221.26 (free base); 63.01 (nitrate ion)

• Advantages

• As a nitrate impurity of Nilotinib, this compound has the following advantages:
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• Well-defined and highly characteristic structure: A salt structure containing guanidino, methylbenzoate ethyl ester, and nitrate ion, significantly different from the benzamide pyrimidine structure of Nilotinib. It can be accurately identified by techniques like HPLC and ion chromatography, providing a specific marker for impurity detection;

• High stability and traceability: The nitrate form is stable under acidic conditions. As a residual nitrate salt of guanidino intermediates in Nilotinib synthesis, it directly reflects incomplete salt formation reactions, improving the accuracy of process tracing;

• High detection sensitivity: The strong polarity and UV absorption (around 210nm) of nitrate ions enable trace analysis via HPLC-UV or ion chromatography, reducing detection costs and enhancing method applicability.

• Applications

• Pharmaceutical quality control: Used as an impurity reference standard to identify and quantify Nilotinib Impurity 32(Nitrate) in Nilotinib APIs and formulations, ensuring residual guanidino intermediate nitrates meet quality standards;

• Synthesis process optimization: Reducing nitrate impurity formation by monitoring its content and optimizing nitric acid dosage and pH conditions in salt formation reactions to improve product purity;

• Salt stability studies: Used to evaluate the stability of guanidino intermediate salt formation processes in Nilotinib synthesis, assisting in assessing the impact of nitrate impurities on final product quality.

• Background Description

• Nilotinib is a tyrosine kinase inhibitor used in the treatment of chronic myeloid leukemia (CML). Its synthesis involves guanidinobenzoate ethyl ester intermediates. Incomplete salt formation with nitric acid or inadequate purification may generate impurities like ethyl 3-guanidino-4-methylbenzoate nitrate. Nitrate impurities may affect chemical stability of the drug, making their control a key part of Nilotinib quality assurance.

• Research Status

• Current research focuses on:
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• Detection method optimization: Using UPLC-DAD to optimize detection conditions based on the synergistic absorption of nitrate ions and guanidino groups, achieving trace detection of this impurity (detection limits up to ppm level);

• Salt formation process improvement: Enhancing guanidine-nitric acid salt formation efficiency by adjusting reaction temperature and nitric acid addition rate to reduce residual impurities;

• Hydrolysis behavior studies: Investigating the hydrolysis trend of this nitrate impurity under high temperature and humidity to evaluate its potential impact on Nilotinib formulation shelf life;

• Impurity limit setting: Establishing rational limits for this impurity based on toxicological data and production consistency, integrating it into Nilotinib's quality control strategy.

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 17386083646
E-mail: anna@molcoo.com