Description

Erlotinib Impurity G CAS NO 882420-21-5 is a high-purity reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Erlotinib Hydrochloride. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of this specific impurity during drug manufacturing. It is an essential material for quality control laboratories, analytical scientists, and regulatory affairs professionals working in the development and production of Erlotinib-based oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Erlotinib Impurity G in drug substances and products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, to monitor impurity profiles.
• Quality Control and Assurance (QC/QA): Used in routine batch release testing to ensure Erlotinib API and finished drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation and level of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Erlotinib Impurity G
CAS No.	882420-21-5
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Erlotinib N-Oxide Impurity; Tarceva Impurity G; CP-358774 Impurity G; OSI-774 Impurity G; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-; Erlotinib Related Compound G
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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