Doxylamine EP Impurity D, PurCert

PurCert


Linear Formula:  C12H9NO
Molecular Weight:  183.21 g/mol
CAS Number: 91-02-1

Properties

Water Solubility insoluble
Assay Purity >=99%
Refractive index n20/D 1.588
B pt. 317 °C
M pt. 41 - 43 °C
Density 1.556 g/cm3
Form Solid

Safety Information

Hazard Statement(s) H315-H319-H335
Precautionary Statement  P261-P305+P351+P338
GHS Pictogram
Signal word Warning
HS Code 29333990
Flash point 302 °F
Storage Temp. 2-8 °C
Storage Class 11 - Combustible Solids
UN Number NA

Description

Application
Doxylamine EP Impurity D is used as a pharmaceutical reference standard for analytical method development method validation quality control testing and impurity profiling of doxylamine drug substances and formulations.

Purpose
Its purpose is to identify quantify and control impurity levels during the manufacture and quality assessment of doxylamine ensuring compliance with pharmacopoeial and regulatory requirements.

General Description
Doxylamine EP Impurity D is a specified pharmacopoeial impurity associated with the manufacture and quality control of the antihistamine drug doxylamine. It is chemically known as 2-benzoylpyridine (phenyl(pyridin-2-yl)methanone) and is used as a reference standard in analytical testing.