Description

Erlotinib Impurity 93 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Erlotinib, an important tyrosine kinase inhibitor medication. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and CROs (Contract Research Organizations) involved in method development, stability studies, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Erlotinib Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation in HPLC, UPLC, and LC-MS systems for impurity monitoring.
• Stability Studies and forced degradation studies to understand the degradation pathways of Erlotinib.
• Quality Control (QC) and Quality Assurance (QA) processes in GMP (Good Manufacturing Practice) environments.
• Regulatory Submissions to agencies like the FDA and EMA, providing necessary impurity characterization data.
• Research and Development of Erlotinib generics and related pharmaceutical formulations.

Basic Information

Product Name	Erlotinib Impurity 93
CAS No.	1620397-61-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 93; Erlotinib EP Impurity K; Tarceva Impurity 93; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Impurity; Erlotinib Specified Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 93 is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch undergoes rigorous testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 (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.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.