1466663
USP
N-Nitrosodiisopropylamine (NDIPA)
United States Pharmacopeia (USP) Reference Standard
Synonym(s):
N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP
About This Item
Recommended Products
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
Storage Class Code
3 - Flammable liquids
WGK
WGK 3
Flash Point(F)
49.5 °F
Flash Point(C)
9.7 °C
Regulatory Listings
Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.
FSL
Group 4: Flammable liquids
Alcohols
Hazardous rank II
ISHL Indicated Name
Substances Subject to be Indicated Names
ISHL Notified Names
Substances Subject to be Notified Names
JAN Code
1466663-1ML:4548173370408
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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