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Key Documents

Y0002262

N-Nitroso-ethyl-isopropylamine

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

N-Ethyl-N-nitroso-2-propanamine solution

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About This Item

Empirical Formula (Hill Notation):
C5H12N2O
CAS Number:
16339-04-1
Molecular Weight:
116.16
UNSPSC Code:
41116107
NACRES:
NA.24

manufacturer/tradename

EDQM

concentration

in methanol

application(s)

pharmaceutical

storage temp.

2-8°C

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

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

Application

N-Nitroso-ethyl-isopropylamine EP reference standard is intended for use only as specifically prescribed in the European Pharmacopoeia.

It is also used to prepare N-Nitrosamines spiking solution to detect the concentration of N-nitrosamines in active substances according to the monograph 20542 of European Pharmacopoeia.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

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

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Articles

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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