Description

Afatinib Impurity 75 is a specified organic impurity used as a reference standard in the analytical research and development of the active pharmaceutical ingredient (API) Afatinib. This high-purity compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and quality control processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Afatinib and its related substances.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and transferring chromatographic methods to monitor impurities in Afatinib API and drug formulations.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Quality Control & Batch Release: Employed as a system suitability standard and for setting specification limits in the routine QC testing of Afatinib batches to ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) to support drug approval and market authorization.
• Research on Degradation Pathways: Aids in understanding the chemical degradation profile and metabolic pathways of Afatinib.

Basic Information

Product Name	Afatinib Impurity 75
CAS No.	2348580-72-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 75; Afatinib Impurity C; Afatinib Specified Impurity; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Afatinib EP Impurity C; Afatinib USP Impurity; Giotrif Impurity
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 75 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and ensure high purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and other critical parameters. Our quality standards align with ICH Q3A(R2) and Q3B(R2) 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.