Doxylamine EP Impurity C PurCert

PurCert


Linear Formula:  C16H20N2O
Molecular Weight:  256.34 g/mol
CAS Number: 1221-70-1 (free base)

Properties

Assay Purity >=95%
B pt. NA
M pt. NA
Form Liquid

Safety Information

Hazard Statement(s) NA
Precautionary Statement  NA
GHS Pictogram
Signal word NA
HS Code NA
Storage Temp. 2-8°C
UN Number NA

Description

Application
Used as a reference standard in pharmaceutical analytical testing. Employed in impurity profiling and characterization studies. Utilized in HPLC UPLC and LC-MS method development and validation. Applied in stability-indicating studies to evaluate degradation behavior. Supports compliance with European Pharmacopoeia specifications and regulatory requirements.

Purpose
The primary purpose of Doxylamine EP Impurity C is to facilitate the identification quantification and control of related impurities in doxylamine drug substances and finished products ensuring their quality safety efficacy and regulatory compliance

General Description
Doxylamine EP Impurity C is a specified related substance described in the European Pharmacopoeia (EP) for the quality control of Doxylamine. It is a known impurity that may arise during the synthesis processing storage or degradation of doxylamine and is monitored as part of pharmaceutical quality assurance programs.