1466685
USP
N-Nitrosoethylisopropylamine (NEIPA)
United States Pharmacopeia (USP) Reference Standard
Synonym(s):
N-Ethyl-N-nitroso-2-propanamine, EIPNA, NEIPA
About This Item
Recommended Products
packaging
pkg of 1 mg
manufacturer/tradename
USP
application(s)
pharmaceutical (small molecules)
format
neat
storage temp.
−20°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
Application
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
Other Notes
related product
signalword
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
3 - Flammable liquids
wgk_germany
WGK 3
flash_point_f
49.5 °F
flash_point_c
9.7 °C
Certificates of Analysis (COA)
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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.
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