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
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
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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