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USP

N-Nitrosodimethylamine (NDMA)

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

N-Methyl-N-nitrosomethanamine, NDMA

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About This Item

Empirical Formula (Hill Notation):
C2H6N2O
CAS Number:
62-75-9
Molecular Weight:
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

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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.

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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?1469? NITROSAMINE IMPURITIES
United States Pharmacopeia, 46(5) (2021)

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>.

N-Nitrosamines Determination in Valsartan

GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.

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