1466652
USP
N-Nitrosodiethylamine (NDEA)
United States Pharmacopeia (USP) Reference Standard
Synonym(s):
N-Ethyl-N-nitrosoethanamine, NDEA
About This Item
grade
pharmaceutical primary standard (
)
API family
nifedipine
form
liquid
packaging
pkg of 1 mg
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecules)
format
neat
storage temp.
−20°C
SMILES string
N(N=O)(CC)CC
InChI
1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3
InChI key
WBNQDOYYEUMPFS-UHFFFAOYSA-N
General description
N-Nitrosodiethylamine is a carcinogenic compound that is strictly regulated within the biologics and pharmaceutical industries. Although not used as an ingredient, its presence is monitored in biologic products, as trace amounts can be toxic. NDEA is studied extensively for its potential health risks, and its detection is critical to ensuring the safety and regulatory compliance of biologic formulations.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
Application
It is also used to prepare standard, standard stock, nitrosamineRS stock, Nitrosamine standards stock solution mixture, and sensitivity stocksolutions to determine NDEA impurity in drug substances and drug products(valsartan, irbesartan, and losartan potassium etc.) by chromatography methodaccording to the general chapter <1469> of United States Pharmacopeia.
Analysis Note
Other Notes
Signal Word
Danger
Hazard Statements
Precautionary Statements
Hazard Classifications
Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1
Target Organs
Eyes,Central nervous system
Storage Class Code
3 - Flammable liquids
WGK
WGK 3
Flash Point(F)
49.5 °F
Flash Point(C)
9.7 °C
Regulatory Information
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Articles
An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.
This application note describes the LC-MS-based quantitative analysis of known nitrosamine impurities following procedures 1 and 3 as given in USP general chapter <1469>.
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
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