PHR2407

N-Nitrosodimethylamine (NDMA)

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): N-Nitrosodimethylamine, NDMA, Dimethylnitrosamine
• Linear Formula: (CH₃)₂NNO
• CAS Number: 62-75-9
• Molecular Weight: 74.08
• UNSPSC Code: 41116107
• NACRES: NA.24
• MDL number: MFCD00002053

Properties

• Quality Level: 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
• manufacturer/tradename: Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
• 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

Description

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.

Safety Information

• pictograms: GHS06,GHS08,GHS09
• signalword: Danger
• hcodes: H300 + H330,H350,H372,H411
• pcodes: P202 - P260 - P264 - P271 - P273 - P304 + P340 + P310
• 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