N-Nitroso Meglumine Impurity, PurCert

PurCert


Properties

Assay Purity >=99%
Refractive index n20/D 1.4665
B pt. 365.61 °C
Density 1.3760 g/cm3
Form Solid

Safety Information

Hazard Statement(s) H302-H350
Precautionary Statement  P501-P270-P202-P201-P264-P280-P308+P313-P301+P312+P330-P405
GHS Pictogram
Signal word Danger
Storage Temp. 2-8 °C
UN Number 2811

Description

Application
N-Nitroso Meglumine Impurity is used as a reference impurity in pharmaceutical analytical testing and research studies. It is mainly applied during impurity profiling and quality control of medicines containing meglumine or related compounds.

Purpose
The purpose of N-Nitroso Meglumine Impurity is to help detect identify and quantify nitrosamine-related contamination in pharmaceutical products.

General Description
N-Nitroso Meglumine Impurity is a nitrosamine impurity that can form from meglumine under certain manufacturing or storage conditions in the presence of nitrosating agents. Because nitrosamines may have potential carcinogenic risk this impurity is carefully monitored in pharmaceutical analysis.