Description

Erlotinib Impurity 58 CAS NO 2246399-22-2 is a designated impurity 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 serving as a reference marker in chromatographic analysis. 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 oncology therapeutics.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Erlotinib Impurity 58 in Erlotinib API and finished drug products.
• Critical component in method development and validation for HPLC and UPLC analyses in pharmaceutical quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles and establish shelf-life specifications.
• Essential for regulatory compliance and filing, supporting applications to agencies like the US FDA, EMA, and other global health authorities.
• Serves as a research tool for studying the degradation pathways and metabolism of Erlotinib.
• Supports pharmacopoeial testing to meet standards set by USP, EP, or other compendia.

Basic Information

Product Name	Erlotinib Impurity 58
CAS No.	2246399-22-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 58; Erlotinib EP Impurity 58; Erlotinib USP Impurity 58; Tarceva Impurity 58; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; (Specific IUPAC name to be confirmed); Erlotinib Degradation Product; Erlotinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Impurity 58 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC) to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results 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). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

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 ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.