Fasudil Nitroso Impurity 26 NEW

Fasudil Nitroso Impurity 26

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

• Product Information

• Product Number: F012026

• English Name: Fasudil Nitroso Impurity 26

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

• CAS Number: 72782-14-0

• Molecular Formula: C₅H₁₁N₃O

• Molecular Weight: 129.16

• Advantages

• As a mononitroso derivative impurity of Fasudil, this compound has the following advantages:
• 
  

• Well-defined and distinct structure: Contains a 1,4-diazepane skeleton with a single nitroso (-NO) substituent. Compared with Fasudil's hexahydro-1H-1,4-diazepine core, the introduction of nitroso group results in significant differences in polarity and mass spectral response, enabling accurate identification via HPLC and LC-MS as a specific marker for impurity detection;

• High stability and traceability: The conjugated structure of nitroso group and diazepane ring is stable under dark conditions. As a product of partial nitrosation of amino groups in Fasudil synthesis, it directly reflects the incompleteness of nitrosation reaction, improving the accuracy of process tracing;

• High detection sensitivity: The conjugated system of nitroso group shows characteristic UV absorption (230-240nm), and combined with specific mass spectral response (m/z 130 [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 26 in Fasudil APIs and formulations, ensuring residual mononitroso impurities meet quality standards;

• Synthesis process optimization: Optimizing reagent ratios (e.g., nitrite dosage) and reaction time of nitrosation by monitoring impurity content to reduce mononitroso 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, airtight packaging).

• 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 two nitrosatable amino groups). During synthesis or storage (especially when exposed to nitrites or acidic environments), incomplete nitrosation may generate 1-nitroso-1,4-diazepane (mononitroso substitution), namely Fasudil Nitroso Impurity 26. Nitrosamines have potential genotoxicity, making their control a key part of Fasudil quality assurance.

• Research Status

• Current research focuses on:
• 
  

• Detection method optimization: Using UPLC-MS/MS with optimized parameters based on characteristic fragment ions of nitroso groups (e.g., NO⁺) to achieve trace detection (detection limits up to ppb level);

• Nitrosation kinetics: Studying impurity formation rates under varying pH and reaction time to clarify key factors driving partial amino nitrosation in Fasudil;

• Toxicological assessment: Evaluating genotoxic potential via in vitro assays (e.g., micronucleus test) to establish scientifically based impurity limits;

• Inhibition strategies: Developing nitrosation-inhibiting additives (e.g., ascorbic acid) to minimize impurity formation in 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