Description

Doxylamine Ep Impurity A CAS NO 873407-01-3 is a high-purity reference standard specifically identified as a process-related impurity of Doxylamine Succinate. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Doxylamine-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Doxylamine Succinate.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA, ICH) to demonstrate thorough impurity characterization and control strategies.
• Quality Control Testing: Acts as a system suitability and identification standard in routine QC release testing of Doxylamine Succinate batches.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Doxylamine Ep Impurity A
CAS No.	873407-01-3
Molecular Formula	C17H22N2O
Molecular Weight	270.37 g/mol
Synonyms	Doxylamine Impurity A; Doxylamine Related Compound A; N,N-Dimethyl-2-(1-phenyl-1-(2-pyridinyl)ethoxy)ethanamine; Doxylamine Succinate Impurity A; Doxylamine EP Impurity A; Doxylamine USP Impurity A; Doxylamine Process Impurity; UNII-9M3H5W51AX (component)
EINECS	Contact for details

Quality Control

Our Doxylamine Ep Impurity A is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 at 2-8°C. Handle the material under an inert atmosphere if necessary to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
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% w/w

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