Description

Afatinib Impurity I CAS NO 1637254-93-3 is a high-purity reference standard specifically identified and characterized for use in pharmaceutical development and quality control. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Afatinib, a targeted therapy used in oncology. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, enabling precise identification, quantification, and monitoring of this specific impurity during production and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Afatinib.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Afatinib API to monitor and control impurity levels against ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to track the formation and growth of this impurity over time under various storage conditions.
• Research and Development: Used in pharmaceutical R&D to study the degradation pathways and chemistry of Afatinib.

Basic Information

Product Name	Afatinib Impurity I
CAS No.	1637254-93-3
Molecular Formula	C24H25ClFN5O3
Molecular Weight	485.94 g/mol
Synonyms	Afatinib Related Compound I; Afatinib Impurity 1; (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide; N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[(3S)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide; Giotrif Impurity I; Gilotrif Impurity I
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity I is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the results against predefined specifications. Our quality standards align with the requirements for pharmaceutical reference materials and support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.