Description

Erlotinib Impurity 9 (CAS No. 2055840-54-3) is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity in the synthesis and formulation of the active pharmaceutical ingredient Erlotinib, an important tyrosine kinase inhibitor. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require precise standards for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Erlotinib Impurity 9 in drug substance and drug product analysis.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure Erlotinib batches meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Erlotinib formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over the manufacturing process and product quality.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Erlotinib Impurity 9
CAS No.	2055840-54-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 9; Erlotinib Specified Impurity 9; Erlotinib EP Impurity I; Erlotinib USP Impurity; Tarceva Impurity 9; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; (Erlotinib Intermediate Related Substance)
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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