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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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Pack SizeSKUAvailabilityPrice
1 mL
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PLN 2,960.00

About This Item

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

PLN 2,960.00


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grade

pharmaceutical primary standard (

)

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

General description

Nitrosamines are chemical compounds that can form during drug manufacturing and may pose health risks, including carcinogenicity.

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

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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format

neat

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format

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format

neat

grade

pharmaceutical primary standard (

)

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard (

)

grade

pharmaceutical primary standard (

)

storage temp.

−20°C

storage temp.

-

storage temp.

−20°C

storage temp.

−20°C

manufacturer/tradename

USP

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

manufacturer/tradename

USP

manufacturer/tradename

USP

packaging

pkg of 1 mg

packaging

pkg of 1 mL

packaging

pkg of 1 mg

packaging

pkg of 1 mg


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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


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.

67-56-1

CAS No.


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Certificates of Analysis (COA)

Lot/Batch Number

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Articles

Niniejsza nota aplikacyjna opisuje opartą na LC-MS analizę ilościową znanych zanieczyszczeń nitrozoaminowych zgodnie z procedurami 1 i 3 podanymi w rozdziale ogólnym USP <1469>.

An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.

GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.

View All Articles

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.

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.

Zamów spośród szerokiej gamy wysoce scharakteryzowanych podstawowych referencyjnych materiałów wzorcowych do stosowania z monografiami USP-NF do testowania substancji leczniczych i postaci dawkowania, farmaceutycznych substancji pomocniczych, składników żywności i suplementów diety.

View All Related Content

?1469? NITROSAMINE IMPURITIES
United States Pharmacopeia, 46(5) (2021)



Global Trade Item Number

SKUGTIN
1466641-1ML04065265949743

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