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PHR2407

Supelco

N-Nitrosodimethylamine (NDMA)

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

N-Nitrosodimethylamine, NDMA, Dimethylnitrosamine

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About This Item

Linear Formula:
(CH3)2NNO
CAS Number:
62-75-9
Molecular Weight:
74.08
MDL number:
MFCD00002053
UNSPSC Code:
41116107

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

agency

traceable to USP 1466674

vapor pressure

5 mmHg ( 20 °C)

form

liquid

CofA

current certificate can be downloaded

packaging

pkg of 100 mg

refractive index

n20/D 1.437 (lit.)

bp

153 °C/774 mmHg (lit.)

density

1.01 g/mL (lit.)

application(s)

pharmaceutical

storage temp.

2-8°C

SMILES string

CN(C)N=O

InChI

1S/C2H6N2O/c1-4(2)3-5/h1-2H3

InChI key

UMFJAHHVKNCGLG-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. It is analyzed using GMP validated instruments as per pharmacopeia monograph methods and is traceable to Unites States Pharmacopeia (USP), European Pharmacopeia (EP), and British Pharmacopeia (BP) primary standards, wherever applicable.

It is provided with a comprehensive certificate of analysis (CoA) containing a certified purity value, calculated by the mass balance approach. All information regarding the use of this CRM can be found on the certificate of analysis.N-Nitrosodimethylamine (NDMA) is a nitrosamine that occurs as an impurity in sartan angiotensin II receptor blocker drugs.

Application

N-Nitrosodimethylamine CRM may also find uses as given below:

  • Determination of N-Nitrosodimethylamine (NDMA) as an impurity in four valsartan APIs and tablets by high-performance liquid chromatography (HPLC)
  • Quantitative analysis of NDMA in valsartan pharmaceutical formulations by capillary electrophoresis-nanospray-mass spectrometry
  • Simultaneous determination of N-nitrosodimethylamine and N-nitrosomethylethylamine in drug substances and products containing sartans, ranitidine, and metformin by solid-phase extraction (SPE) and gas chromatography-tandem mass spectrometry (GC-MS/MS)
  • Analysis of NDMA in the olmesartan API and tablets by high-performance liquid chromatography-mass spectrometry (HPLC-MS)
  • Development and validation of an HPLC-MS/MS method for separation and quantification of NDMA impurity for quality control of ranitidine products

Biochem/physiol Actions

Induces gastric, liver, kidney and lung cancer in mice and rats.

Other Notes

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC4355 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

signalword

Danger

Hazard Classifications

Acute Tox. 1 Inhalation - Acute Tox. 2 Oral - Aquatic Chronic 2 - Carc. 1B - STOT RE 1

target_organs

Liver

Storage Class

6.1A - Combustible, acute toxic Cat. 1 and 2 / very toxic hazardous materials

wgk_germany

WGK 3

flash_point_f

141.8 °F - closed cup

flash_point_c

61.0 °C - closed cup

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAC8369
LRAC4355
LRAC8369
LRAC4355

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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.

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