Doxylamine N-oxide Hydrochloride Impurity, PurCert

PurCert


Properties

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

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 pharmaceutical reference standard in drug quality control. Employed in impurity profiling and stability studies of doxylamine-containing products. Used during method development and validation of analytical techniques such as HPLC LC-MS and related assays. Helps manufacturers comply with regulatory requirements for impurity identification and quantification.

Purpose
The primary purpose of Doxylamine N-oxide Hydrochloride Impurity is to serve as a reference material for monitoring identifying and quantifying oxidative degradation products of doxylamine in pharmaceutical substances and finished dosage forms ensuring

General Description
Doxylamine N-oxide Hydrochloride Impurity is an oxidative degradation product (impurity) of the antihistamine drug Doxylamine. It is formed when the tertiary amine group of doxylamine undergoes oxidation producing the corresponding N-oxide which may be isolated or characterized as its hydrochloride salt.