Description

Afatinib Impurity 77 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Afatinib. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Afatinib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Afatinib Impurity 77 in drug substance and drug product batches.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control & Assurance (QC/QA): Used in routine impurity monitoring to ensure Afatinib API and finished drug products comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to track impurity profiles and degradation pathways in stability-indicating studies for Afatinib formulations.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and controlling the formation of this specific impurity during the synthesis and purification stages of Afatinib manufacturing.

Basic Information

Product Name	Afatinib Impurity 77
CAS No.	26404-20-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 77; Afatinib EP Impurity G; Afatinib USP Impurity; BIBW 2992 Impurity 77; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide; Gilotrif Impurity 77; Giotrif Impurity 77
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 77 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to maintain stability.

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 individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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