Description

Erlotinib Impurity 48 is a designated impurity associated with the active pharmaceutical ingredient Erlotinib Hydrochloride. This compound is critical for pharmaceutical research and development, specifically for analytical method development and quality control processes. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure the purity, safety, and efficacy of Erlotinib-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Erlotinib Hydrochloride drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods used in quality control laboratories.
• Stability Studies: Used to monitor impurity profiles during forced degradation and long-term stability studies of Erlotinib formulations.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis of Erlotinib, enabling process optimization.
• Quality Assurance/Quality Control (QA/QC): Used as a system suitability standard and for routine batch release testing to ensure product specifications are met.

Basic Information

Item	Details
Product Name	Erlotinib Impurity 48
CAS No.	2304005-44-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 48; Erlotinib Impurity K; Erlotinib EP Impurity K; Tarceva Impurity 48; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)- (Related Substance)
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Impurity 48 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.