Description

Afatinib Impurity Jxh is a designated impurity of the active pharmaceutical ingredient Afatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is an essential material for analytical method development, validation, and ensuring compliance with stringent regulatory requirements for impurity profiling. Quality-focused organizations in the pharmaceutical and biotechnology sectors require this compound to guarantee the safety, efficacy, and quality of their final drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Afatinib drug substance and drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity thresholds and control strategies as per ICH guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the level of Impurity Jxh in commercial batches of Afatinib.
• Stability Studies: Used as an analytical marker to track the formation of this impurity under various stress conditions and during shelf-life studies.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Afatinib to minimize the formation of this specific impurity.

Basic Information

Product Name	Afatinib Impurity Jxh
CAS No.	2223677-60-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound Jxh; Afatinib Specified Impurity J; Afatinib EP Impurity J; Afatinib USP Impurity J; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity Jxh; Gilotrif Impurity Jxh
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity Jxh is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 compound is hygroscopic (moisture-sensitive); 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 structure
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.