Description

Doxylamine Ep Impurity C CAS NO 1442-21-3 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of doxylamine succinate, a widely used antihistamine. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories who require precise impurity profiling and method validation.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in doxylamine succinate active pharmaceutical ingredient (API) and finished dosage forms.
• Method development and validation for analytical techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and mass spectrometry.
• Critical component in stability studies and forced degradation studies to monitor impurity formation under various stress conditions.
• Used for regulatory compliance and filing, supporting applications to agencies like the FDA, EMA, and other global health authorities.
• Essential for quality control (QC) laboratories to establish acceptance criteria and ensure batch-to-batch consistency of pharmaceutical products.
• Supports research and development in synthetic chemistry for route optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Doxylamine Ep Impurity C
CAS No.	1442-21-3
Molecular Formula	C17H22N2O
Molecular Weight	270.37 g/mol
Synonyms	N,N-Dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]ethanamine; Doxylamine Related Compound C; Doxylamine Impurity C; 2-[α-[2-(Dimethylamino)ethoxy]-α-methylbenzyl]pyridine; 1-Phenyl-1-(2-pyridinyl)ethoxy-N,N-dimethylethanamine; Doxylamine EP Impurity C; Doxylamine Succinate Impurity C
EINECS	Contact for details

Quality Control

Every batch of Doxylamine Ep Impurity C is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis, to ensure compliance with pharmacopeial standards such as EP (European Pharmacopoeia) and USP (United States Pharmacopeia). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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