Description

Afatinib Impurity 123 is a specified organic impurity associated with the active pharmaceutical ingredient Afatinib, a tyrosine kinase inhibitor. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies involved in the development and production of Afatinib and its generic formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Afatinib drug substance and drug product batches.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the sensitivity and specificity of impurity detection methods.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during Afatinib manufacturing.

Basic Information

Product Name	Afatinib Impurity 123
CAS No.	127322-74-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 123; Afatinib Specified Impurity 123; (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; BIBW 2992 Impurity 123; Gilotrif Impurity 123; Giotrif Impurity 123
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 123 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) that detail batch-specific results, ensuring traceability and compliance with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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