Description

Afatinib Impurity 11/Des-(4-Dimethylamino-2-En-1-Oxo)Butylamino 6-(5-Hydroxy-Pyrrolidin-2-On-1-Yl) Afatinib is a structurally defined impurity and degradation product of the active pharmaceutical ingredient (API) Afatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for method validation, stability studies, and ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments involved in the production and quality control of Afatinib-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Afatinib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Afatinib and to establish appropriate storage conditions and shelf-life.
• Quality Control & Assurance (QC/QA): A critical component in the batch release testing of Afatinib to ensure compliance with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings (e.g., with FDA, EMA) to support drug approval and marketing authorization.
• Research on Drug Metabolism and Pharmacokinetics (DMPK): Used in studies to investigate the metabolic fate and pharmacokinetic behavior of Afatinib and its related substances.

Basic Information

Product Name	Afatinib Impurity 11/Des-(4-Dimethylamino-2-En-1-Oxo)Butylamino 6-(5-Hydroxy-Pyrrolidin-2-On-1-Yl) Afatinib
CAS No.	2223677-58-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Impurity 11; Des-(4-Dimethylamino-2-En-1-Oxo)Butylamino 6-(5-Hydroxy-Pyrrolidin-2-On-1-Yl) Afatinib; Afatinib Related Compound 11; Afatinib Degradant; (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-{[(3S)-tetrahydro-3-furanyl]oxy}quinazolin-6-yl]-4-(dimethylamino)-2-butenamide Impurity; BIBW 2992 Impurity 11; Giotrif Impurity; Gilotrif Impurity
EINECS	Contact for details

Quality Control

Our Afatinib Impurity 11 is manufactured under controlled conditions to ensure the highest standards of identity, purity, and stability. Each batch undergoes rigorous analytical testing using advanced techniques like HPLC, LC-MS, and NMR to confirm its structure and purity profile. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a reference standard in compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry environment. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, consider storing under an inert atmosphere.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.