Description

Afatinib Impurity 12 is a specified impurity and degradation product 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, stability studies, and regulatory compliance. It is essential for quality control laboratories, analytical chemists, and pharmaceutical manufacturers engaged in the production and validation 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 & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies & Forced Degradation: Employed to understand degradation pathways of Afatinib and to establish shelf-life specifications.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control & Batch Release: Acts as a system suitability standard in routine QC testing to ensure the purity and safety of commercial Afatinib batches.
• Research on Metabolism & Pharmacokinetics: Used in studies to investigate the metabolic fate and pharmacokinetic behavior of Afatinib and related compounds.

Basic Information

Product Name	Afatinib Impurity 12
CAS No.	402573-46-0
Molecular Formula	C24H25ClFN5O3
Molecular Weight	485.94 g/mol
Synonyms	Afatinib Related Compound 12; Afatinib Impurity B; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide; BIBW 2992 Impurity 12; Gilotrif Impurity 12; Giotrif Impurity 12; Tovok Impurity 12
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with ICH guidelines and supports cGMP-compliant applications.

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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
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.