N-Nitrosodiisopropylamine (NDIPA) Impurity PurCert

PurCert


Linear Formula:  C6H14N2O
Molecular Weight:  130.19 g/mol
CAS Number: 601-77-4

Properties

Assay Purity >=99%
B pt. 194.5 °C
M pt. 48 °C
Density 0.9422
Form Solid

Safety Information

Hazard Statement(s) H302,H350
Precautionary Statement  P202 - P264 - P280 - P301 + P312 - P308 + P313 - P405
GHS Pictogram
Signal word Danger
HS Code 38229010
Storage Temp. 2-8 °C
Storage Class 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
UN Number NA

Description

Application
N-Nitrosodiisopropylamine (NDIPA) impurity is used as an analytical reference standard in pharmaceutical quality control method development validation and impurity profiling to monitor and limit nitrosamine contamination in drug substances and drug products.

Purpose
The primary purpose of N-Nitrosodiisopropylamine (NDIPA) impurity reference material is to support the detection identification quantification and control of NDIPA during analytical testing to ensure product quality and regulatory compliance.

General Description
N-Nitrosodiisopropylamine (NDIPA) is a nitrosamine compound that can occur as a process-related impurity in the manufacture of certain pharmaceuticals chemicals and other industrial products.