Description

Afatinib Impurity 6 CAS NO 2413212-07-2 is a high-purity chemical reference standard specifically identified and characterized for pharmaceutical analysis. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Afatinib, a targeted therapy used in oncology. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments engaged in method development, validation, and impurity profiling to meet stringent global regulatory requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Afatinib drug substance and drug products.
• Method Development & Validation: Crucial for developing and validating robust analytical methods (e.g., HPLC, UPLC) to monitor and control impurity levels throughout the manufacturing process.
• Stability Studies: Used to identify and quantify degradation products that may form in Afatinib formulations under various stress conditions (heat, light, humidity).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity identification and specification limits.
• Quality Control Testing: Employed in routine batch release testing of Afatinib API to ensure it meets the purity specifications outlined in pharmacopeial monographs or internal quality standards.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Afatinib synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Afatinib Impurity 6
CAS No.	2413212-07-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 6; Afatinib EP Impurity 6; Afatinib USP Impurity 6; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity 6; Giotrif Impurity 6; Gilotrif Impurity 6; BIBW 2992 Impurity 6
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, test results, and chromatograms. Our quality standards are designed to support compliance with ICH Q3A/B, USP, and EP 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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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 ≤ 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.