1466663
USP
N-Nitrosodiisopropylamine (NDIPA)
United States Pharmacopeia (USP) Reference Standard
Synonym(s):
N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP
About This Item
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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
Application
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
Other Notes
related product
Signal Word
Danger
Hazard Statements
Precautionary Statements
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)
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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.
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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