Description

Erlotinib Impurity 1 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Erlotinib. This compound is critical for ensuring the purity, safety, and efficacy of Erlotinib-based drug products by enabling accurate identification and quantification of this specific impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of targeted cancer therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Erlotinib Impurity 1 in drug substance and drug product analysis.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control and Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure Erlotinib API and finished products comply with stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination and regulatory filings.
• Regulatory Compliance and Submissions: Provides necessary data for regulatory documentation, including Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification stages of Erlotinib manufacturing.

Basic Information

Product Name	Erlotinib Impurity 1
CAS No.	2204518-92-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 1; Erlotinib EP Impurity 1; Erlotinib USP Impurity 1; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; Tarceva Impurity 1; OSI-774 Impurity 1; CP-358774 Impurity 1
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines (Q3A, Q6A) and relevant pharmacopeial standards, ensuring the material is fit for its intended use as a high-purity reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

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

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