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About This Item
SMILES string
N(N=O)(CCCC)CCCC
InChI
1S/C8H18N2O/c1-3-5-7-10(9-11)8-6-4-2/h3-8H2,1-2H3
InChI key
YGJHZCLPZAZIHH-UHFFFAOYSA-N
grade
pharmaceutical primary standard (
)
packaging
pkg of 1 mg
manufacturer/tradename
USP
application(s)
pharmaceutical (small molecules)
format
neat
storage temp.
−20°C
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General description
This product is provided as delivered and specified by the issuing Pharmacopoeia. For further information and support, including certificate/ product information sheets, please go to the website of the issuing Pharmacopoeia.
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
signalword
Danger
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
3 - Flammable liquids
wgk
WGK 2
flash_point_f
49.5 °F
flash_point_c
9.7 °C
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Articles
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>.
Visión general de los ensayos de las impurezas nitrosamínicas, las regulaciones mundiales y las consideraciones clave en la selección de los filtros para la preparación y el análisis de las muestras.
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.
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.
Haga su pedido de una amplia gama de materiales de referencia primarios muy caracterizados para utilizar con las monografías de la USP-NF pensadas para el análisis de sustancias farmacológicas y formas de administración, excipientes farmacéuticos, ingredientes y suplementos alimentarios.
Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.
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