Description

Afatinib Impurity 17 is a designated impurity of the active pharmaceutical ingredient (API) Afatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Afatinib drug substances and products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Afatinib API and finished drug products.
• Critical for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies to monitor degradation pathways and establish shelf-life for Afatinib formulations.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing necessary impurity profiles and characterization data.
• Essential for process chemistry research to understand and control impurity formation during Afatinib synthesis.
• Utilized in academic and institutional research studying the metabolism and pharmacokinetics of Afatinib.

Basic Information

Product Name	Afatinib Impurity 17
CAS No.	1870880-09-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 17; Afatinib Impurity; Afatinib EP Impurity 17; Afatinib USP Impurity; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity; Gilotrif Impurity; BIBW 2992 Impurity 17
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with ICH guidelines for impurities in new drug substances (Q3A(R2)). Our quality commitment supports your needs for reliable reference materials in GMP and research environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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