Description

Erlotinib Impurity 94 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Erlotinib Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the anti-cancer drug Erlotinib.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Erlotinib HCl API and its finished drug products.
• Method Development & Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and UPLC, to detect and quantify this specific impurity.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against strict ICH guidelines, ensuring every batch meets predefined specifications.
• Stability Studies: Employed to track the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to health authorities like the FDA and EMA.
• 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 94
CAS No.	154669-16-6
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	Erlotinib Related Compound 94; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; 6,7-Bis(2-methoxyethoxy)-N-(3-ethynylphenyl)quinazolin-4-amine; Tarceva Impurity 94; CP-358774 Impurity 94; OSI-774 Impurity 94
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 94 is manufactured under strict quality management systems. Each batch undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance requirements.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

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

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