1466674
USP
N-Nitrosodimethylamine (NDMA)
United States Pharmacopeia (USP) Reference Standard
Recommended Products
packaging
pkg of 1 mg
manufacturer/tradename
USP
application(s)
pharmaceutical (small molecules)
format
single component solution (solution in methanol)
storage temp.
−20°C
InChI
1S/C2H6N2O/c1-4(2)3-5/h1-2H3
InChI key
UMFJAHHVKNCGLG-UHFFFAOYSA-N
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 NDMA impurity in drug substances and drug products(valsartan, irbesartan, and losartan potassium etc.) by chromatography method according to the general chapter 〈1469〉 of United States Pharmacopeia.
Analysis Note
Other Notes
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
Regulatory Information
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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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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