Description

Afatinib Impurity 18 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 pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities during drug manufacturing. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting method validation, stability studies, and regulatory compliance for Afatinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Afatinib drug substance and drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control and Batch Release Testing: Serves as a system suitability test component and an external standard for impurity assay in quality control laboratories.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Documentation and Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that require impurity identification.

Basic Information

Product Name	Afatinib Impurity 18
CAS No.	2413212-25-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 18; Afatinib Specified Impurity 18; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity 18; Gilotrif Impurity 18; BIBW 2992 Impurity 18
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 18 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and quality. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, LC-MS, and NMR. We support compliance with ICH Q3A/B guidelines and pharmacopoeial standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. 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)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.