Description

Afatinib Impurity 4 CAS NO 2512206-82-3 is a specified impurity of the active pharmaceutical ingredient Afatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development, production, and regulatory compliance of Afatinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Afatinib drug substance and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and quantify impurities in Afatinib.
• Quality Control & Assurance: Serves as a system suitability standard and for impurity profiling to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification in regulatory filings (e.g., FDA, EMA) for drug approval.
• Stability Studies: Used to monitor the formation and level of this specific impurity under various stress conditions during drug product shelf-life studies.
• Pharmacopoeial Testing: Supports testing to meet monograph specifications for Afatinib in pharmacopoeias such as USP or EP.

Basic Information

Item	Details
Product Name	Afatinib Impurity 4
CAS No.	2512206-82-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 4; Afatinib Specified Impurity 4; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Afatinib EP Impurity D; Afatinib USP Impurity D; Afatinib Process Impurity; Afatinib Degradant
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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