Letermovir Nitroso Impurity NEW

Letermovir Nitroso Impurity；2763779-41-3

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

• Product Information

• Product Number: L043057

• English Name: Letermovir Nitroso Impurity 57

• English Alias: 1-(3-methoxyphenyl)-4-nitrosopiperazine

• CAS Number: 2763779-41-3

• Molecular Formula: C₁₁H₁₅N₃O₂

• Molecular Weight: 221.26

• Advantages

• As a nitroso impurity of Letermovir, this compound has the following advantages:
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• Well-defined and highly characteristic structure: Its unique structure containing nitroso (-NO), methoxyphenyl, and piperazine ring is significantly different from the pyrrolopyrimidinone structure of Letermovir. It can be accurately identified by techniques like HPLC and GC-MS, providing a specific marker for impurity detection;

• High stability and traceability: The conjugated structure formed by nitroso and piperazine ring is relatively stable under dark conditions. As a by-product of amino oxidation in Letermovir synthesis, it directly reflects the oxidation degree of piperazine ring amino groups, improving the traceability accuracy of oxidation control in the process;

• High detection sensitivity: The strong polarity and conjugated system of nitroso group show characteristic absorption in the UV region (230-250nm), enabling trace analysis via HPLC-UV, reducing detection costs and enhancing method applicability.

• Applications

• Pharmaceutical quality control: Used as an impurity reference standard to identify and quantify Letermovir Nitroso Impurity 57 in Letermovir APIs and formulations, ensuring residual nitroso impurities from amino oxidation meet quality standards;

• Synthesis process optimization: Reducing nitroso impurity formation by monitoring its content and optimizing antioxidant conditions in the reaction system (e.g., adding inert gas protection);

• Stability evaluation: Used to assess the oxidative degradation trend of Letermovir formulations during storage, assisting in verifying the sealing and antioxidant properties of packaging materials.

• Background Description

• Letermovir is a cytomegalovirus (CMV) inhibitor used to prevent CMV infection in immunocompromised patients. Its structure contains piperazine ring derivatives. During synthesis or storage, the amino group on the piperazine ring may be oxidized to form nitroso impurities such as 1-(3-methoxyphenyl)-4-nitrosopiperazine. Nitroso compounds may have potential toxicity (e.g., carcinogenicity), making their control a key part of ensuring Letermovir safety.

• Research Status

• Current research focuses on:
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• Detection method optimization: Using UPLC-MS/MS technology to optimize ionization conditions based on the electronegativity of nitroso groups, achieving trace detection of this impurity (detection limits up to ppb level);

• Oxidation mechanism analysis: Clarifying the formation kinetics of this nitroso impurity by simulating different storage conditions (e.g., light exposure, oxygen exposure) to elucidate the oxidation pathway of piperazine rings in Letermovir;

• Toxicological evaluation: Assessing the genotoxicity of this nitroso compound through in vitro chromosome aberration tests to support strict impurity limit standards;

• Process improvement: Developing piperazine derivative synthesis processes under hypoxic environments to reduce amino oxidation reactions and lower the formation of this impurity.

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