Description

Erlotinib Impurity C is a specified impurity associated with the active pharmaceutical ingredient Erlotinib Hydrochloride, used in the manufacture and quality control of the anticancer drug. This high-purity reference standard is critical for pharmaceutical research, development, and quality assurance processes, ensuring drug safety and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Erlotinib and its related substances.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly HPLC and LC-MS, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Employed in the routine QC testing of Erlotinib Hydrochloride drug substance and drug products to monitor impurity levels.
• Stability Studies: Used to identify and quantify degradation products formed during forced degradation and long-term stability studies of Erlotinib formulations.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Process Chemistry Research: Aids in the optimization of synthetic routes by identifying and tracking process-related impurities.

Basic Information

Product Name	Erlotinib Impurity C
CAS No.	1312937-41-9
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity C; Erlotinib Related Compound C; Tarceva Impurity C; CP-358774 Impurity C; 6,7-Bis(2-methoxyethoxy)-N-(3-ethynylphenyl)quinazolin-4-amine Impurity; EGFR Inhibitor Impurity C
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo 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 each shipment to support your regulatory and quality 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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.