Description

Erlotinib Impurity 22 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Erlotinib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The use of high-purity impurity standards is essential for method validation, stability studies, and meeting stringent regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Erlotinib Impurity 22 in drug substances and products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity profiling.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing of Erlotinib API to monitor and control impurity levels as per ICH guidelines.
• Stability Studies: Utilized to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research and Development: Aids in process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Erlotinib Impurity 22
CAS No.	950596-59-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 22; Erlotinib EP Impurity J; Erlotinib USP Impurity; N-[3-ethynylphenyl]-6,7-bis(2-methoxyethoxy)quinazolin-4-amine impurity; Tarceva Impurity 22; 6,7-Bis(2-methoxyethoxy)quinazolin-4-amine, N-(3-ethynylphenyl)-, Impurity; Erlotinib Process Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 22 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail batch-specific results, ensuring compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert conditions if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.