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Supelco

N-Nitrosodiethylamine (NDEA) solution

certified reference material, 5000 μg/mL in methanol

Synonym(s):

Diethylnitrosamine

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About This Item

CAS Number:
55-18-5
MDL number:
MFCD00013890
UNSPSC Code:
41116105

grade

certified reference material
TraceCERT®

Quality Level

100

product line

TraceCERT®

CofA

current certificate can be downloaded

packaging

ampule of 1 mL

concentration

5000 μg/mL in methanol

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

cleaning products
cosmetics
environmental
food and beverages
personal care

format

single component solution

storage temp.

2-8°C

InChI

1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3

InChI key

WBNQDOYYEUMPFS-UHFFFAOYSA-N

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General description

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.

N-Nitrosodiethylamine belongs to the group of toxic nitrosamines, known to show carcinogenic, mutagenic, and hepatotoxic properties. It is formed as a byproduct during food processing, pharmaceutical processing, and water treatment. As a result, they are generally found in water, fish, meat, drug substances, etc.

Application

The CRM can be used as follows:
  • Simultaneous analysis of N-nitrosodiethanolamine, N-nitrosodiethylamine, triethanolamine, diethanolamine in cosmetic samples using liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS)
  • Solid phase extraction of N-nitrosodimethylamine and N-nitrosomethylethylamine from eight sartans, ranitidine, and metformin and also the fortified products of these drugs, for quantification by gas chromatography-tandem mass spectrometry (GC-MS/MS)
  • Multi-residue analysis of seven restricted nitrosamines in two body creams and two shower gel samples by vortex-assisted reversed-phase dispersive liquid-liquid microextraction (VA-RP-DLLME) and liquid chromatography-mass spectrometry (LC-MS)
  • Quantitative analysis of four nitrosamines in four sartan drug substances— candesartan cilexetil, olmesartan medoxomi, irbesartan, and valsartan, by gas chromatography-tandem mass spectrometry (GC-MS/MS)
  • Determination of eight volatile nitrosamines in 28 popular meat product samples using ultrasonic solvent extraction combined with solid phase microextraction (SPME) and GC-MS

Other Notes

Refer to the product′s Certificate of Analysis for more information on a suitable instrument technique. Contact Technical Service for further support.

Legal Information

TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany

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Danger

Hazard Classifications

Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1

Storage Class

3 - Flammable liquids

wgk_germany

WGK 3

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD4465
LRAD2460
LRAC7895
LRAC5384
LRAC2419

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Kei Tamura et al.
The Journal of toxicological sciences, 41(6), 801-811 (2016-11-18)
To clarify the major pathway of liver tumor development induced by imazalil (IMA), an imidazole fungicide, male constitutive androstane receptor (CAR)-knockout (CARKO) and wild-type (WT) mice were treated with IMA at 500 ppm in the diet up to 27 weeks
Hao Hu et al.
International journal of medical sciences, 17(13), 1897-1908 (2020-08-14)
Retinal dehydrogenase 5 (RDH5) is an important enzyme in the visual cycle. Several studies have reported that the RDH family may play crucial roles in tumor prognosis. However, the role of RDH5 in tumor prognosis is still unclear. We examined
Xu Zheng et al.
Nutrients, 10(3) (2018-03-03)
Thyroid cancer (TC) is the most common endocrine malignancy without reliable preventive agent. Resveratrol possesses in vitro anti-TC activities; while its effect(s) on thyroid tumorigenesis remains unknown. This study aims to address this issue using DEN/MNU/DHPN-induced rat carcinogenesis model. 50
L Verna et al.
Pharmacology & therapeutics, 71(1-2), 57-81 (1996-01-01)
N-Nitrosodiethylamine (NDEA) is DNA reactive after bioactivation and produces tumors in every animal species tested. Bioactivation is effected by several P450 isozymes including CYP2E1, which is ethanol inducible. Tumor formation in rat liver was proportional to O4-ethyldeoxythymidine formation in DNA
Esther Bertran et al.
Hepatology (Baltimore, Md.), 58(6), 2032-2044 (2013-07-03)
Transforming growth factor-beta (TGF-β) is an important regulatory suppressor factor in hepatocytes. However, liver tumor cells develop mechanisms to overcome its suppressor effects and respond to this cytokine by inducing other processes, such as the epithelial-mesenchymal transition (EMT), which contributes
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Articles

LC-MS/MS Analysis of N-Nitrosodimethylamine in Valsartan Dispersible Tablets using a Titan™ C18 UHPLC column

Learn about LC-MS/MS method development to quantify NDMA impurity in valsartan drug substance using Titan™ C18 column based UHPLC separation

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.

Protocols

US EPA Method 8270 (Appendix IX): GC Analysis of Semivolatiles on Equity®-5 (30 m x 0.25 mm I.D., 0.50 μm)

US EPA Method 8270 (Appendix IX): GC Analysis of Semivolatiles on Equity®-5 (30 m x 0.25 mm I.D., 0.50 μm)

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