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1466674

USP

N-Nitrosodimethylamine (NDMA)

United States Pharmacopeia (USP) Reference Standard

Sinónimos:

N-Methyl-N-nitrosomethanamine, NDMA

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About This Item

Fórmula empírica (notación de Hill):
C2H6N2O
Número de CAS:
62-75-9
Peso molecular:
74.08
UNSPSC Code:
41116107
NACRES:
NA.24

packaging

pkg of 1 mg

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecules)

format

single component solution (solution in methanol)

storage temp.

−20°C

InChI

1S/C2H6N2O/c1-4(2)3-5/h1-2H3

InChI key

UMFJAHHVKNCGLG-UHFFFAOYSA-N

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-Nitrosodimethylamine (NDMA) USP reference standard is intended for use only as specificallyprescribed in the United States Pharmacopoeia.

It is also used to prepare standard, standard stock, nitrosamine RS stock, nitrosamine standards stock solution mixture, and sensitivity stock solutions to determine NDMA impurity in drug substances and drug products(valsartan, irbesartan, and losartan potassium etc.) by chromatography method according 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.

signalword

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

3 - Flammable liquids

wgk_germany

WGK 3

flash_point_f

49.5 °F

flash_point_c

9.7 °C

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Artículos

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

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.

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