Afatinib Impurity C(Bismaleate) NEW

Product Information

Product Number: A003003A

English Name: Afatinib Impurity C(Bismaleate)

English Alias: (R,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)but-2-enamide dimaleate

CAS Number: None

Molecular Formula: C₂₄H₂₅ClFN₅O₃·2C₄H₄O₄

Molecular Weight: 718.08

Analyzing the by-product formation mechanism of amination and salification reactions during afatinib synthesis to optimize processes for controlling maleate impurity generation;

Serving as a reference standard containing chlorine, fluorine substituents, and quinazoline rings to provide a standard substance for detecting multi-functional group impurities in drugs, improving the quantitative accuracy of methods such as LC-MS;

Helping study the impact of maleate structures on drug stability and crystal form to provide a scientific basis for impurity control strategies.

Applications

Drug Development: Used as an impurity reference standard to identify and quantify Impurity C in afatinib 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 the impurity content meets ICH guideline requirements during production;

Stability Studies: Investigating the hygroscopicity and degradation behavior of maleate structures under high humidity conditions to assist in establishing product storage conditions.

Background Description

Research Status

Synthesis Methods: Developing high-purity synthesis processes for Impurity C to solve the purification challenges of multi-functional group salt compounds;

Detection Technologies: Establishing trace detection methods for this impurity using ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) technology;

Crystal Form Studies: Studying the crystal form characteristics of bismaleate and its impact on drug stability through X-ray diffraction (XRD) analysis;

Process Control: Analyzing the impact of parameters such as pH value and temperature in salification reactions on impurity generation, optimizing conditions to reduce the generation of bismaleate impurities.