Description

Afatinib Impurity 9 CAS NO 2170273-17-1 is a designated process-related impurity and degradation product of the active pharmaceutical ingredient Afatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This high-purity reference standard is critical for analytical method development, validation, and quality control during the manufacturing and regulatory submission of Afatinib drug substances and products. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) focused on oncology drug development and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified external standard for the identification and quantification of Afatinib Impurity 9 in drug substance and drug product batches.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods as per ICH Q2(R1) guidelines.
• Stability Studies & Forced Degradation: Employed to monitor impurity profiles and establish degradation pathways in Afatinib under various stress conditions (heat, light, humidity, acid/base).
• Quality Control & Batch Release: Critical for setting and testing against impurity specification limits to ensure batch-to-batch consistency and safety.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research into Degradation Mechanisms: Used in academic and industrial research to study the chemical behavior and formation pathways of this specific impurity.

Basic Information

Item	Detail
Product Name	Afatinib Impurity 9
CAS No.	2170273-17-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 9; Afatinib Specified Impurity 9; Afatinib EP Impurity I; Afatinib USP Impurity; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; BIBW 2992 Impurity 9; Gilotrif Impurity 9; Giotrif Impurity 9
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 9 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity analysis using advanced techniques such as HPLC, NMR, and MS to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (CoA) is provided with each lot, detailing identity, purity, and impurity profile. Our quality commitment aligns with the needs of GMP/GLP-compliant environments and supports regulatory submissions.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider desiccants or storage under an inert atmosphere.

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)	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.