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1466696

USP

N-Nitrosomethylaminobutyric Acid (NMBA)

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

4-[Methyl(nitroso)amino]butanoic acid

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About This Item

Empirical Formula (Hill Notation):
C5H10N2O3
CAS Number:
Molecular Weight:
146.14
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/C5H10N2O3/c1-7(6-10)4-2-3-5(8)9/h2-4H2,1H3,(H,8,9)

InChI key

SJLBIPLIGYWGJV-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-Nitrosomethylaminobutyric Acid (NMBA) USP reference standard is intended for use only as specifically prescribed in the United States Pharmacopoeia.

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

FlameExclamation mark

Signal Word

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2

Storage Class Code

3 - Flammable liquids

WGK

WGK 2

Flash Point(F)

35.6 °F

Flash Point(C)

2 °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

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>.

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