Description

Erlotinib Hydrochloride Impurity CAS NO 882420-22-6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Erlotinib Hydrochloride. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for the production of targeted cancer therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Erlotinib Hydrochloride API batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Release Testing: Employed in routine QC laboratories to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Aids in forced degradation and long-term stability studies to understand the degradation pathways of Erlotinib Hydrochloride.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Process Chemistry Research: Used to trace the origin of impurities during API synthesis, helping to optimize manufacturing processes for higher purity.

Basic Information

Product Name	Erlotinib Hydrochloride Impurity
CAS No.	882420-22-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound; Erlotinib HCl Impurity; Tarceva Impurity; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Hydrochloride Impurity; Erlotinib Process Impurity; EGFR Inhibitor Impurity; CP-358774 Impurity
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Hydrochloride Impurity (CAS 882420-22-6) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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