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PHR3608

N-Nitrosodibutylamine (NDBA)

certified reference material, pharmaceutical secondary 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
UNSPSC Code:
41116107
NACRES:
NA.24
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1466641

form

methanol solution

CofA

current certificate can be downloaded

packaging

pkg of 1 mL

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

application(s)

pharmaceutical

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

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.

Application

N-Nitrosodibutylamine (NDBA) pharmaceutical secondary reference standard is used for the determination of NDBA concentration in water samples via HPLC method in conjunction with a diode array detector.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

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Solvent

Description
  • 1000 ug/mL solution in methanol

pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Warning

hcodes

H302,H351

Hazard Classifications

Acute Tox. 4 Oral - Carc. 2

Storage Class

12 - Non Combustible Liquids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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

HPLC Separation of Nitrosamines with Supel Carbon LC

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

Related Content

Nitrosamines in Pharmaceuticals

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.

Evaluation of a method for the simultaneous quantification of N-nitrosamines in water samples based on stir bar sorptive extraction combined with high-performance liquid chromatography and diode array detection
Talebpour, Z et al.
Journal of Separation Science, 38, 1601-1609 (2015)

Global Trade Item Number

SKUGTIN
PHR3608-1ML04065267401355