Description

Afatinib Impurity 23 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Afatinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Afatinib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Afatinib formulations.
• Process Chemistry Research: Aids in understanding and optimizing the Afatinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Afatinib Impurity 23
CAS No.	1314777-66-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 23; Afatinib Impurity C; BIBW 2992 Impurity 23; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Afatinib EP Impurity C; Afatinib USP Impurity; Giotrif Impurity 23
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP) and ICH guidelines. 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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