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1466641

USP

N-Nitrosodibutylamine (NDBA)

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

N-Butyl-N-nitroso-1-butanamine

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About This Item

Empirical Formula (Hill Notation):
C8H18N2O
CAS Number:
924-16-3
Molecular Weight:
158.24
MDL number:
MFCD00013892
UNSPSC Code:
41116107
NACRES:
NA.24

packaging

pkg of 1 mg

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecules)

format

neat

storage temp.

−20°C

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

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General description

This product is provided as delivered and specified by the USP Pharmacopoeia. For further information and support, including certificate/ product information sheets, please go to the website of the issuing Pharmacopoeia.

Application

N-Nitrosodibutylamine (NDBA) USP reference standard is intended for use only as specifically prescribed in the United States Pharmacopoeia.

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

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

Sales restrictions may apply.

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Description
Pricing

Signal Word

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 Code

3 - Flammable liquids

WGK

WGK 2

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.

EU REACH Annex XVII (Restriction List)

CAS No.

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Certificates of Analysis (COA)

Lot/Batch Number

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Articles

Determination of N-Nitrosamines in Valsartan

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.

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