Description

Afatinib Impurity 9 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Afatinib. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by accurately identifying and quantifying related substances. It is an essential tool for pharmaceutical R&D laboratories, quality assurance departments, and regulatory affairs teams involved in the development and manufacturing of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Afatinib API and drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods such as HPLC and UPLC.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity levels and ensure batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification stages of Afatinib manufacturing.

Basic Information

Product Name	Afatinib Impurity 9
CAS No.	2413212-17-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 9; Afatinib Impurity; Afatinib Specified Impurity; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity; Gilotrif Impurity
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 9 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (e.g., HPLC, MS, NMR) to ensure compliance with the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment and handled with appropriate precautions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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