1466674
USP
N-Nitrosodimethylamine (NDMA)
United States Pharmacopeia (USP) Reference Standard
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
Related Categories
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
Storage Class Code
3 - Flammable liquids
WGK
WGK 3
Flash Point(F)
49.5 °F
Flash Point(C)
9.7 °C
Regulatory Information
Certificates of Analysis (COA)
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Example:
Additional examples:
705578-5MG-PW
PL860-CGA/SHF-1EA
MMYOMAG-74K-13
1000309185
enter as 1.000309185)
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Aldrich Products
For a lot number such as TO09019TO, enter it as 09019TO (without the first two letters 'TO').
For a lot number with a filling-code such as 05427ES-021, enter it as 05427ES (without the filling-code '-021').
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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>.
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.
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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