Description

Afatinib Impurity 19 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Afatinib, a targeted therapy used in oncology. It serves as a key marker for identification and quantification during method development, stability studies, and regulatory compliance testing. Pharmaceutical manufacturers, analytical laboratories, and research institutions require this high-purity impurity standard to meet stringent pharmacopeial guidelines.

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 robust HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control impurity levels in Afatinib drug substance and finished dosage forms.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and specification data.
• Research and Development: Facilitates studies on the degradation pathways, metabolism, and synthesis of Afatinib and related compounds.

Basic Information

Product Name	Afatinib Impurity 19
CAS No.	1245555-42-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 19; Afatinib Specified Impurity 19; Afatinib EP Impurity I; Afatinib USP Impurity; BIBW 2992 Impurity 19; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 19 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We support compliance with major pharmacopeial standards (USP, EP, ICH) and can provide materials suitable for method validation and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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