Description

Afatinib Impurity 74 CAS NO 1259015-90-1 is a high-purity chemical 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 is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for meeting stringent regulatory requirements in drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Afatinib Impurity 74 in Afatinib drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP environments to ensure impurity levels are within ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies of Afatinib to understand degradation pathways and establish shelf-life.
• Research & Development: Used in process chemistry R&D to optimize synthesis routes and minimize the formation of this specific impurity.

Basic Information

Product Name	Afatinib Impurity 74
CAS No.	1259015-90-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 74; Afatinib EP Impurity I; Afatinib USP Impurity; Afatinib Process 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

Our Afatinib Impurity 74 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results and traceability. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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