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1466652

USP

N-Nitrosodiethylamine (NDEA)

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

N-Ethyl-N-nitrosoethanamine, NDEA

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About This Item

Empirical Formula (Hill Notation):
C4H10N2O
CAS Number:
55-18-5
Molecular Weight:
102.14
UNSPSC Code:
41116107
NACRES:
NA.24

packaging

pkg of 1 mg

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecules)

format

neat

storage temp.

−20°C

InChI

1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3

InChI key

WBNQDOYYEUMPFS-UHFFFAOYSA-N

Related Categories

General description

This product is provided as delivered and specified by the USP Pharmacopoeia. For further information and support, including certificate/ product information sheets, please go to the website of the issuing Pharmacopoeia.

Application

N-Nitrosodiethylamine (NDEA) USP reference standard is intended for use only as specificallyprescribed in the United States Pharmacopoeia.

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

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

Sales restrictions may apply.

Signal Word

Danger

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Articles

Determination of N-Nitrosamines in Valsartan

Nitrosamines have been discovered as a serious contaminant group in active pharmaceutical ingredients (API) belonging to the sartan family. This article describes a GC-MS method for the determination of nitrosamines in Valsartan tablets according to US FDA guide lines that can be used for pharma QC.

LC-MS/MS Analysis of N-Nitrosodimethylamine in Valsartan Dispersible Tablets using a Titan™ C18 UHPLC column

Learn about LC-MS/MS method development to quantify NDMA impurity in valsartan drug substance using Titan™ C18 column based UHPLC separation

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