Description

Afatinib Impurity Sho CAS NO 2223677-65-2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety, efficacy, 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 research institutions engaged in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Afatinib drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Essential for routine batch release testing in GMP environments to ensure impurity levels are within ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability protocols.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop robust purification processes.

Basic Information

Product Name	Afatinib Impurity Sho
CAS No.	2223677-65-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound Sho; Afatinib Impurity; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Sho Afatinib Impurity; Afatinib Degradant; Giotrif Impurity; Gilotrif Impurity; Afatinib Process Impurity
EINECS	Contact for details

Quality Control

Our Afatinib Impurity Sho is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC). A detailed Certificate of Analysis (COA) is provided, documenting the analytical results and confirming compliance with in-house specifications aligned with ICH guidelines. We support regulatory needs with full traceability and documentation.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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