Description

Afatinib Impurity 18 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, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Afatinib drug substances and products.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Afatinib API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Afatinib.
• Essential for regulatory submissions (e.g., ANDA, NDA) to establish impurity profiles and specifications.
• Supports research and development of synthetic routes and purification processes for Afatinib.
• Utilized in pharmacopoeial testing to ensure compliance with standards set by USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Afatinib Impurity 18
CAS No.	1449430-53-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 18; Afatinib Impurity; Afatinib EP Impurity; 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
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against predefined specifications. We support compliance with ICH Q3A/B guidelines and pharmacopoeial standards (USP, EP).

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 should be kept in a dry environment. For long-term storage, consider storing under inert conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified 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.