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1466652

USP

N-Nitrosodiethylamine (NDEA)

Name: <I>N</I>-Nitrosodiethylamine (NDEA)
Brand: USP

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

Analytical Reference Standards

Pharmacopeia & Metrological Institute Standards

Reference Materials

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.

Pictograms

GHS02,GHS06,GHS08

Signal Word

Danger

Hazard Statements

H225,H301 + H311 + H331,H350,H370

Precautionary Statements

P201 - P210 - P280 - P301 + P310 - P303 + P361 + P353 - P304 + P340 + P311

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

Evaluation of Millex^® Syringe Filters for Nitrosamine Impurities Testing in Pharmaceutical Drugs

An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.

Quantitative Analysis of Nitrosamine Impurities by LC-MS Methods from the United States Pharmacopeia General Chapter <1469>

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>.

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.