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Merck
CN

1466685

USP

N-Nitrosoethylisopropylamine (NEIPA)

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

N-Ethyl-N-nitroso-2-propanamine, EIPNA, NEIPA

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About This Item

Empirical Formula (Hill Notation):
C5H12N2O
CAS Number:
Molecular Weight:
116.16
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24
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grade

pharmaceutical primary standard (

)

packaging

pkg of 1 mg

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecules)

format

neat

storage temp.

−20°C

SMILES string

N(N=O)(C(C)C)CC

InChI

1S/C5H12N2O/c1-4-7(6-8)5(2)3/h5H,4H2,1-3H3

InChI key

VGGZTNNNXAUZLB-UHFFFAOYSA-N

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General description

Nitrosamines are chemical compounds that can form during drug manufacturing and may pose health risks, including carcinogenicity.

This product is provided as delivered and specified by the issuing Pharmacopoeia. For further information and support, including certificate/ product information sheets, please go to the website of the issuing Pharmacopoeia.

Application

N-Nitrosoethylisopropylamine (NEIPA) 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 NEIPA 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

Storage Class Code

3 - Flammable liquids

WGK

WGK 3

Flash Point(F)

49.5 °F

Flash Point(C)

9.7 °C

Regulatory Information

危险化学品
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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.

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

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>.

大致介绍亚硝胺杂质检测、全球法规以及在样品制备和分析中过滤器选型的主要注意事项。

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Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.

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