N-Nitroso Clozapine NEW

N-Nitroso Clozapine;156632-03-0

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E-mail: anna@molcoo.com

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• Product Information

• Product Number: N031068

• English Name: N-Nitroso Clozapine

• English Alias: 8-chloro-11-(4-methylpiperazin-1-yl)-5-nitroso-5H-dibenzo[b,e][1,4]diazepine

• CAS Number: 156632-03-0

• Molecular Formula: C₁₈H₁₈ClN₅O

• Molecular Weight: 355.82

• Advantages

• As a nitroso derivative impurity of Clozapine, this compound has the following advantages:
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• Well-defined and distinct structure: Contains nitroso (-NO) group, dibenzo[b,e][1,4]diazepine ring, chlorine atom, and methylpiperazinyl, differing from Clozapine by nitroso substitution on the 5-position nitrogen. 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 structure of nitroso group and diazepine ring is highly stable. As a product of amino oxidation during Clozapine storage or metabolism, it directly reflects oxidative degradation, improving quality tracing accuracy;

• High detection sensitivity: The conjugated system of nitroso group shows strong UV absorption (240-260nm), and combined with chlorine isotopic characteristics, trace analysis can be achieved via HPLC-UV or LC-MS, compatible with heterocyclic drug detection systems.

• Applications

• Pharmaceutical quality control: Used as an impurity reference to identify and quantify N-Nitroso Clozapine in Clozapine APIs and formulations, ensuring residual nitroso impurities meet quality standards;

• Stability testing: Assessing oxidative stability of Clozapine formulations under light and high temperature by monitoring impurity levels to guide storage condition design;

• Metabolic studies: Investigating in vivo oxidative metabolism of Clozapine, clarifying formation and clearance pathways of nitroso impurities to support safety evaluation.

• Background Description

• Clozapine is an atypical antipsychotic for treatment-resistant schizophrenia, with a structure containing dibenzo[b,e][1,4]diazepine and oxidizable amino groups. During storage (especially under air or light exposure), amino groups may oxidize to form nitroso derivatives, namely N-Nitroso Clozapine. Nitrosamines have potential genotoxicity, making their control critical for Clozapine quality assurance and safety evaluation.

• Research Status

• Current research focuses on:
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• Detection optimization: Using UPLC-MS/MS with chlorine isotope (³⁵Cl/³⁷Cl) and nitroso fragment monitoring to achieve ultra-trace detection (ppb level);

• Oxidation kinetics: Studying impurity formation rates under varying pH and oxygen levels to identify key drivers of amino oxidation in Clozapine;

• Toxicological assessment: Evaluating genotoxic potential via in vitro assays to establish strict impurity limits;

• Stabilization strategies: Developing oxygen-impermeable packaging and antioxidant additives to minimize nitroso impurity formation in Clozapine products.

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