N-Nitroso Benazepril
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Well-defined and distinct structure: A complex structure containing nitroso (-N=O) group, benzazepine ring, phenylbutane ester chain, and acetic acid moiety, differing from Benazepril by nitroso substitution on the amino group. 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 N-nitrosamine structure is relatively stable under neutral conditions. As a product of amino group oxidation during Benazepril storage or degradation, it directly reflects the degree of oxidative deterioration, improving the accuracy of quality tracing;
High detection sensitivity: The conjugated system of nitroso group has characteristic absorption in the UV region (230-250nm), and combined with the polarity of ester and carboxyl groups, trace analysis can be achieved via HPLC-UV or LC-MS, compatible with conventional detection systems.
Pharmaceutical quality control: Used as an impurity reference standard to identify and quantify N-Nitroso Benazepril in Benazepril APIs and formulations, ensuring residual nitroso impurities from storage or production meet quality standards;
Stability evaluation: Assessing the oxidative deterioration trend of Benazepril formulations under different storage conditions (e.g., temperature, light) by monitoring the impurity content, providing data support for formulating reasonable storage conditions;
Degradation mechanism research: Exploring the degradation pathway of Benazepril in oxidative environments, clarifying the formation conditions of nitroso impurities, and assisting in optimizing antioxidant processes in production.
Benazepril is an angiotensin-converting enzyme inhibitor (ACEI) used in the treatment of hypertension and heart failure, with a structure containing oxidizable amino groups. During storage (especially when exposed to air, light, or high temperature), amino groups may be oxidized to form nitroso derivatives, namely N-Nitroso Benazepril. N-nitrosamines have potential genotoxicity and carcinogenicity, so their control is an important part of Benazepril quality assurance and safety evaluation.
Current research focuses on:
Detection method optimization: Using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) technology, optimizing detection parameters by utilizing characteristic fragment ions of nitroso groups (such as NO⁺), to achieve trace detection of this impurity (detection limit up to ppb level);
Oxidation kinetics analysis: Studying the formation rate of this impurity by simulating different pH and oxygen concentration conditions, clarifying the key influencing factors of amino group oxidation in Benazepril;
Toxicity assessment: Evaluating the potential hazards of this impurity through in vitro cell genotoxicity tests (such as comet assay), providing a scientific basis for formulating strict impurity limit standards;
Development of stabilization technologies: Developing light-shielding and oxygen-barrier packaging materials (such as aluminum-plastic blisters) or adding antioxidants (such as butylated hydroxyanisole) to inhibit the formation of this nitroso impurity during Benazepril 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
China
