N-Nitrosodimethylamine
SIAL/PHR2407
Synonym: N-Nitrosodimethylamine; NDMA; Dimethylnitrosamine
CAS Number: 62-75-9
Empirical Formula (Hill Notation): C2H6N2O
Molecular Weight: 74.08
MDL Number: MFCD00002053
Linear Formula: (CH3)2NNO
Product Type: Chemical
| bp | 153 °C/774 mmHg (lit.) |
| CofA | current certificate can be downloaded |
| density | 1.01 g/mL (lit.) |
| description | Pharmaceutical Secondary Standard; Certified Reference Material |
| form | liquid |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C2H6N2O/c1-4(2)3-5/h1- |
| InChI key | UMFJAHHVKNCGLG-UHFFFAOYSA |
| packaging | pkg of 100 mg |
| Quality Level | 300  |
| refractive index | n |
| SMILES string | CN(C)N=O |
| storage temp. | 2-8°C |
| vapor pressure | 5 mmHg ( 20 °C) |
| Application: | N-Nitrosodimethylamine CRM may also find uses as given below:• Determination of N-Nitrosodimethylamine (NDMA) as an impurity in four valsartan APIs and two tablets by high-performance liquid chromatography (HPLC) • Quantitative analysis of NDMA in valsartan pharmaceutical formulations by capillary electrophoresis-nanospray • 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. |
| 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. |
| 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. |
| 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. |
| Symbol |    GHS06,GHS08,GHS09 |
| Signal word | Danger |
| Hazard statements | H300 + H330 - H350 - H372 - H411 |
| Precautionary statements | P201 - P202 - P260 - P264 - P273 - P304 + P340 + P310 |
| WGK Germany | WGK 3 |
| Flash Point(F) | 141.8 °F - closed cup |
| Flash Point(C) | 61.0 °C - closed cup |
| bp | 153 °C/774 mmHg (lit.) |
| Density | 1.01 g/mL (lit.) |
| Refractive Index | n |
| Storage Temp. | 2-8°C |
| UNSPSC | 41116107 |