Description

Erlotinib Impurity Q is a designated impurity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Erlotinib Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, process optimization, and regulatory compliance of Erlotinib-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Erlotinib Impurity Q in Erlotinib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and specifications.
• Process Chemistry Research: Aids in understanding and optimizing the Erlotinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Erlotinib Impurity Q
CAS No.	1417161-98-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound Q; Erlotinib EP Impurity Q; Erlotinib USP Impurity Q; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; Tarceva Impurity Q; CP-358774 Impurity Q; OSI-774 Impurity Q
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity Q is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR), to ensure it meets the high 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 pharmacopeial guidelines.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if recommended for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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