Description

Erlotinib Hydrochloride Impurity 44 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in Erlotinib Hydrochloride drug substance and finished products. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance for oncology medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling: Identification and quantification of this specific impurity in Erlotinib Hydrochloride Active Pharmaceutical Ingredient (API) during stability studies and release testing.
• Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC) or Ultra-High-Performance Liquid Chromatography (UPLC) methods for impurity analysis.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for specified impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control Laboratories: Used in routine QC testing of Erlotinib batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) and in-house specifications.
• Research & Development: Employed in studies to understand the formation, fate, and purge of this impurity during the synthetic process of Erlotinib Hydrochloride.

Basic Information

Product Name	Erlotinib Hydrochloride Impurity 44
CAS No.	1470063-80-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 44; Erlotinib HCl Impurity 44; Tarceva Impurity 44; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Hydrochloride Impurity; Erlotinib Process Impurity 44; Erlotinib Specified Impurity; CP-358774 Impurity 44; OSI-774 Impurity 44
EINECS	Contact for details

Quality Control

Our Erlotinib Hydrochloride Impurity 44 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and establish purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Handle the material in accordance with safe laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets internal specifications
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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