Description

Erlotinib Impurity 77 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the anticancer drug Erlotinib. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification in Erlotinib API and finished drug products.
• Analytical Method Development and Validation (HPLC, LC-MS) for accurate quantification of related substances.
• Quality Control and Release Testing to ensure drug substance and product meet ICH Q3A/B guidelines.
• Stability Studies to monitor impurity levels in Erlotinib formulations under various storage conditions.
• Regulatory Submissions as a characterized impurity reference standard for FDA, EMA, and other agency filings.
• Research and Development of Erlotinib synthesis pathways and degradation studies.

Basic Information

Product Name	Erlotinib Impurity 77
CAS No.	1241475-15-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 77; Erlotinib EP Impurity G; N-[3-ethynylphenyl]-6,7-bis(2-methoxyethoxy)quinazolin-4-amine impurity; Tarceva Impurity 77; 6,7-Bis(2-methoxyethoxy)quinazolin-4-amine, N-(3-ethynylphenyl)-, Impurity; Erlotinib Process Impurity; EGFR Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 77 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is fully characterized and undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis. Certificates of Analysis (COA) with detailed chromatograms and spectroscopic data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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