1466641
USP
N-Nitrosodibutylamine (NDBA)
United States Pharmacopeia (USP) Reference Standard
Synonym(s):
N-Butyl-N-nitroso-1-butanamine
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/C8H18N2O/c1-3-5-7-10(9-11)8-6-4-2/h3-8H2,1-2H3
InChI key
YGJHZCLPZAZIHH-UHFFFAOYSA-N
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General description
Application
It is also used to prepare standard, nitrosamine standards stock solution mixture, and sensitivity solutions to determine NDBA 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 - Flam. Liq. 2 - STOT SE 1
Target Organs
Eyes,Central nervous system
Storage Class Code
3 - Flammable liquids
WGK
WGK 2
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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