N-Nitroso Ebastine EP Impurity
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E-mail: anna@molcoo.com
Product Number: E041015
English Name: N-Nitroso Ebastine EP Impurity C
English Alias: 4-(benzhydryloxy)-1-nitrosopiperidine
CAS Number: None
Molecular Formula: C₁₈H₂₀N₂O₂
Molecular Weight: 296.36
As a nitroso impurity reference standard for ebastine, this compound has the following advantages:
Well-defined structure, which can be used to analyze the by-product formation mechanism of nitrosation reactions during ebastine synthesis or storage, optimizing processes to control nitroso impurity generation;
Serving as a reference standard containing nitroso and piperidine ring structures, providing a standard substance for detecting nitroso impurities in drugs, and helping to evaluate drug safety (nitroso compounds may have potential carcinogenicity);
Helping study the impact of nitroso structures on drug stability and toxicological properties to provide a scientific basis for formulating impurity control strategies.
Drug Development: Used as an impurity reference standard to identify and quantify N-nitroso impurities in ebastine preparations, evaluating the purity of APIs and formulations;
Quality Control: Acting as a standard substance to validate the sensitivity of detection methods (e.g., HPLC or LC-MS), ensuring nitroso impurity content meets ICH guideline requirements during production;
Toxicological Research: Assisting in evaluating the potential genotoxicity of nitroso impurities to provide data support for drug safety evaluation.
Ebastine is apotent and long-acting histamine H1 receptor antagonist used for treating allergic diseases. Due to the potential carcinogenic risk of nitroso compounds (such as N-nitrosamines), drug regulatory authorities worldwide have put forward strict control requirements for nitroso impurities in drugs. N-Nitroso Ebastine EP Impurity C, as an impurity with a nitroso structure in ebastine, may be generated during synthesis, storage, or metabolism. Therefore, research on it is a key link in drug quality control and safety assessment.
Current research focuses on:
Synthesis Methods: Developing high-purity synthesis processes for N-Nitroso Ebastine EP Impurity C, solving the challenge of poor stability of nitroso compounds to meet the needs of toxicological research and quality control;
Detection Technologies: Establishing trace detection methods for nitroso impurities (detection limits reach ppb level) using ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and other technologies;
Toxicological Evaluation: Studying the potential mutagenicity and carcinogenicity of this impurity through in vitro Ames tests and animal models;
Process Control: Analyzing the inducements (such as raw material residues, reaction conditions) of nitrosation reactions to optimize the synthesis route or storage conditions to reduce the generation of nitroso impurities.
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
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