Description

Erlotinib Impurity CAS NO 183321-82-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Erlotinib, a targeted cancer therapy. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is fundamental for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Erlotinib drug substance and finished products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for quality control laboratories.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Erlotinib formulations.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Utilized in pharmacokinetic and metabolic studies to understand the degradation pathways of Erlotinib.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing in GMP environments.

Basic Information

Product Name	Erlotinib Impurity
CAS No.	183321-82-6
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Erlotinib Related Compound; Erlotinib EP Impurity; Tarceva Impurity; CP-358774 Impurity; OSI-774 Impurity; NSC 718781 Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical results. Our quality system is designed to support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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