Description

Erlotinib Impurity A is a specified impurity of the active pharmaceutical ingredient Erlotinib Hydrochloride, a tyrosine kinase inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and batch release of Erlotinib and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Erlotinib Impurity A in drug substances and products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Erlotinib API.
• Quality Control & Assurance: A critical component in the impurity profile testing of Erlotinib batches to ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize the synthesis pathway of Erlotinib to minimize the formation of this specific impurity.

Basic Information

Product Name	Erlotinib Impurity A
CAS No.	183321-85-9
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; 6,7-Bis(2-methoxyethoxy)-N-(3-ethynylphenyl)quinazolin-4-amine; Tarceva Impurity A; Erlotinib Related Compound A; OSI-774 Impurity A; CP-358774 Impurity A; NSC 718781 Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity A is manufactured and handled in a GMP-compliant environment. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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. This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. 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 (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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