Description

Afatinib Impurity Des-Eja is a designated impurity standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Afatinib. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of this specific process-related impurity. It is an essential tool for analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical and biotechnology sectors focused on oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Afatinib.
• Method Development and Validation: Critical for developing and validating robust analytical methods (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Quality Control and Batch Release: Used in QC laboratories to monitor and control the level of Des-Eja impurity in Afatinib API batches to meet ICH guidelines.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Afatinib Impurity Des-Eja
CAS No.	2223677-64-1
Molecular Formula	C22H20ClFN4O2
Molecular Weight	426.87 g/mol
Synonyms	Des-Eja Afatinib; Afatinib Des-Eja Impurity; (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Afatinib Related Compound Des-Eja; N-[4-(3-Chloro-4-fluorophenyl)amino]-7-[(3S)-oxolan-3-yl]oxy-6-quinazolinyl]-4-(dimethylamino)but-2-enamide Impurity; Giotrif Impurity Des-Eja; Gilotrif Impurity Des-Eja
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity Des-Eja CAS 2223677-64-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.