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1466663

USP

N-Nitrosodiisopropylamine (NDIPA)

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP

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About This Item

Empirical Formula (Hill Notation):
C6H14N2O
CAS Number:
Molecular Weight:
130.19
UNSPSC Code:
41116107
NACRES:
NA.24

packaging

pkg of 1 mg (in 1 mL methanol)

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecules)

format

single component solution

storage temp.

−20°C

InChI

1S/C6H14N2O/c1-5(2)8(7-9)6(3)4/h5-6H,1-4H3

InChI key

AUIKJTGFPFLMFP-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-Nitrosodiisopropylamine (NDIPA) USP reference standard is intended for use only as specifically prescribed 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 NDIPA 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.

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

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

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>.

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

Related Content

Accurately detect and quantify trace nitrosamines (NDMA, NDEA, NEIPA, NDIPA, NDBA, etc.) in pharmaceutical drugs using our complete product portfolio and application guides for LC-MS and GC-MS. Order high-quality reference standards, columns, filters & more.

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