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PHR2407

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
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD00002053
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Quality Segment

300

grade

certified reference material, pharmaceutical secondary standard

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

General description

N-Nitrosodimethylamine (NDMA) is a nitrosamine that occurs as an impurity in sartan angiotensin II receptor blocker drugs.

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. It is analyzed using Pharmacopeial compendial methods and/or validated methods, and is traceable to USP, EP standards where 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.

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.
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.

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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

flash_point_f

141.8 °F - closed cup

flash_point_c

61.0 °C - closed cup

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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