Description

Erlotinib Impurity 110 is a high-purity reference standard used in the pharmaceutical development and quality control of the anticancer drug Erlotinib Hydrochloride. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance for Erlotinib API and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Erlotinib and its related substances.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities in Erlotinib drug substance and drug products.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Erlotinib API and finished drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH impurity guidelines.
• Stability Studies: Employed to identify and track degradation products that may form under various stress conditions (heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and process chemistry studies by helping to identify and characterize process-related impurities.

Basic Information

Item	Detail
Product Name	Erlotinib Impurity 110
CAS No.	18193-72-1
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Erlotinib Related Compound 110; Erlotinib EP Impurity J; Erlotinib USP Impurity; Tarceva Impurity 110; CP-358774 Impurity; OSI-774 Impurity; NSC 718781
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Impurity 110 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques such as HPLC, GC, MS, NMR, and IR to confirm identity, purity, and structure. We provide comprehensive Certificates of Analysis (COA) that include batch-specific data, chromatograms, and spectral evidence, ensuring full traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH Q3A/B guidelines for impurities.

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 desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown 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.