Product Number: U003006
English Name: Upadacitinib Impurity 6
English Alias: 1686678.0; (3R,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide
CAS Number: None
Molecular Formula: C₁₇H₁₉F₃N₆O
Molecular Weight: 380.37
As a key related impurity of Upadacitinib, its research is vital for drug development and quality control:
Helps analyze the synthesis process of Upadacitinib to optimize production and reduce impurity formation;
Aids in evaluating drug metabolism, providing references for safety and efficacy studies;
Serves as a reference standard for impurity quantification to ensure drug purity meets pharmacopoeia standards.
Drug Development: Used as an impurity reference standard to identify and quantify the impurity, assisting in drug quality assessment;
Quality Control: Acts as a standard substance to validate the accuracy of detection methods, ensuring drug stability during production and storage;
Toxicological Research: Assists in evaluating the potential impact of the impurity on humans to establish safe impurity limits.
Upadacitinib, a highly selective JAK1 inhibitor, is clinically used for treating immune-related diseases like rheumatoid arthritis and atopic dermatitis. Impurities in drugs may affect efficacy or cause safety issues, making impurity research a core part of drug quality control. Upadacitinib Impurity 6, potentially generated during synthesis or storage, requires systematic study to clarify its source, properties, and control methods.
Current research focuses on:
Synthesis Methods: Developing efficient and high-purity preparation processes to meet research and quality control needs;
Detection Technologies: Establishing highly sensitive impurity analysis methods using LC-MS, NMR, etc.;
Formation Mechanism: Investigating the generation pathway of the impurity during synthesis and storage to optimize processes for reduction;
Safety Assessment: Determining the safe exposure level of the impurity through toxicological experiments to support drug standard formulation
China
