N-Nitroso Desmethyl Cidoxepin NEW

Product Number: N031080

English Name: N-Nitroso Desmethyl Cidoxepin

English Alias: (Z)-N-(3-(dibenzo[b,e]oxepin-11(6H)-ylidene)propyl)-N-methylnitrous amide

CAS Number: None

Molecular Formula: C₁₈H₁₈N₂O₂

Molecular Weight: 294.35

Analyzing the by-product formation mechanism of nitrosation reactions during cidoxepin metabolism or synthesis to optimize processes for controlling nitroso impurity generation;

Serving as a nitroso-class reference standard to provide a standard substance for detecting nitroso impurities in drugs, assisting in evaluating 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 cidoxepin preparations, evaluating the purity of APIs and metabolites;

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.

Synthesis Methods: Developing high-purity synthesis processes for (Z)-configured 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