Description

Afatinib Impurity 21 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Afatinib, a targeted therapy for non-small cell lung cancer. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and batch release testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Afatinib drug substance and drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity levels during API synthesis.
• Regulatory Submission and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Afatinib to identify and track potential degradation products.
• Quality Control (QC) Testing: Serves as a system suitability and identification marker in the routine QC testing of commercial Afatinib batches.
• Process Chemistry Research: Used by R&D chemists to study and optimize the synthetic pathway of Afatinib, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Afatinib Impurity 21
CAS No.	2044709-72-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 21; Afatinib EP Impurity J; Afatinib USP Impurity; Afatinib Process Impurity; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity 21; Gilotrif Impurity 21
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 21 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by NMR and MS, 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.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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