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
• MDL number: MFCD00002053
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• 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

Description

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.

Safety Information

• Pictograms: GHS06,GHS08,GHS09
• Signal Word: Danger
• Hazard Statements: H300 + H330,H350,H372,H411
• Precautionary Statements: 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 Code: 6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
• WGK: WGK 3
• Flash Point(F): 141.8 °F - closed cup
• Flash Point(C): 61.0 °C - closed cup