Description

Erlotinib Impurity 90 is a designated pharmaceutical 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) Erlotinib by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in the development, production, and regulatory compliance of Erlotinib-based drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during Erlotinib API synthesis and purification processes.
• Analytical Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to ensure accurate detection and quantification limits.
• Quality Control and Batch Release Testing: Employed in routine QC testing of Erlotinib drug substances and finished products to confirm compliance with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines on impurities.
• Stability Studies: Used to track the formation and level of this impurity over time in stability studies, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports process chemistry research aimed at optimizing synthesis routes to minimize the formation of this impurity.

Basic Information

Product Name	Erlotinib Impurity 90
CAS No.	1012057-39-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 90; Erlotinib Specified Impurity 90; Tarceva Impurity 90; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; CP-358774 Impurity 90; OSI-774 Impurity 90; NSC 718781 Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 90 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, 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, test methods, and traceability.

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. Handle with appropriate precautions in a well-ventilated area.

Specification

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

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