Fasudil Nitroso Impurity 25 NEW

Fasudil Nitroso Impurity 25

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E-mail: anna@molcoo.com

• Product Information

• Product Number: F012025

• English Name: Fasudil Nitroso Impurity 25

• English Alias: 1,4-dinitroso-1,4-diazepane

• CAS Number: 55557-00-1

• Molecular Formula: C₅H₁₀N₄O₂

• Molecular Weight: 158.16

• Advantages

• As a nitroso derivative impurity of Fasudil, this compound has the following advantages:
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• Well-defined and distinct structure: Contains a 1,4-diazepane skeleton with bis-nitroso (-NO) substituents, showing significant differences from the hexahydro-1H-1,4-diazepine core of Fasudil. 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 bis-nitroso groups and diazepane ring is stable under dark conditions. As a by-product of hexahydrodiazepine ring oxidation in Fasudil synthesis, it directly reflects the degree of amino nitrosation, improving the accuracy of process tracing;

• High detection sensitivity: The conjugated system of nitroso groups has characteristic UV absorption (230-250nm), and combined with specific mass spectral response (m/z 159 [M+H]⁺), trace analysis can be achieved via LC-MS, compatible with detection systems for nitrogen heterocyclic drugs.

• Applications

• Pharmaceutical quality control: Used as an impurity reference standard to identify and quantify Fasudil Nitroso Impurity 25 in Fasudil APIs and formulations, ensuring residual nitroso impurities meet quality standards;

• Synthesis process optimization: Optimizing amino protection/deprotection conditions of hexahydro-1H-1,4-diazepine ring by monitoring impurity content to reduce nitroso by-product formation;

• Stability evaluation: Assessing the oxidative deterioration trend of Fasudil formulations during storage to support the development of appropriate storage conditions (e.g., light protection, low oxygen).

• Background Description

• Fasudil is a Rho kinase inhibitor used to treat cerebral vasospasm after subarachnoid hemorrhage, with a structure containing a hexahydro-1H-1,4-diazepine ring (with oxidizable amino groups). During synthesis or storage (especially when exposed to nitrites or oxidative environments), the two amino groups on the diazepine ring may undergo nitrosation to form 1,4-dinitroso-1,4-diazepane, namely Fasudil Nitroso Impurity 25. Bis-nitroso compounds may have stronger potential toxicity, making their control a key part of Fasudil quality assurance.

• Research Status

• Current research focuses on:
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• Detection method optimization: Using UPLC-MS/MS with optimized parameters based on characteristic fragment ions of bis-nitroso groups to achieve trace detection (detection limits up to ppb level);

• Nitrosation mechanism analysis: Studying the formation kinetics of this impurity by simulating different pH and nitrite concentration conditions, clarifying the key influencing factors of amino bis-nitrosation in Fasudil;

• Toxicological assessment: Evaluating the potential hazards of this bis-nitroso derivative through in vitro genotoxicity tests to provide a scientific basis for formulating strict impurity limit standards;

• Inhibition strategy research: Developing nitrosation inhibitors (e.g., sulfite derivatives) or inert gas protection processes to inhibit the formation of this impurity during Fasudil production and storage

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