Description

Afatinib Impurity 34 is a designated impurity of the active pharmaceutical ingredient Afatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, specifically for method validation, stability studies, and ensuring the safety and efficacy of the final drug product. It is an essential reference standard for quality control laboratories and analytical scientists in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Afatinib drug substance and finished products.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability and Forced Degradation Studies: Employed to identify and monitor the formation of this specific impurity under various stress conditions to establish product shelf-life.
• Quality Control and Batch Release: Serves as a system suitability and identification standard in the routine QC testing of Afatinib to ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to define impurity limits and justify specifications.
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and improve the manufacturing process of Afatinib.

Basic Information

Product Name	Afatinib Impurity 34
CAS No.	2475095-50-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 34; Afatinib Specified Impurity 34; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity 34; Gilotrif Impurity 34; BIBW 2992 Impurity 34
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 34 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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