PHR2407
N-Nitrosodimethylamine (NDMA)
Pharmaceutical Secondary Standard; Certified Reference Material
Synonym(s):
N-Nitrosodimethylamine, NDMA, Dimethylnitrosamine
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About This Item
Product Name
N-Nitrosodimethylamine (NDMA), Pharmaceutical Secondary Standard; Certified Reference Material
InChI
1S/C2H6N2O/c1-4(2)3-5/h1-2H3
SMILES string
CN(C)N=O
InChI key
UMFJAHHVKNCGLG-UHFFFAOYSA-N
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
Quality Level
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Application
- 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
General description
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.
Other Notes
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
WGK 3
flash_point_f
141.8 °F - closed cup
flash_point_c
61.0 °C - closed cup
Regulatory Information
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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Articles
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
亚硝胺经证是沙坦家族活性药物成分 (API) 中的一种严重污染物。本文介绍了一种根据美国 FDA 指南测定缬沙坦片中亚硝胺含量的 GC-MS 方法，适用于药品质量控制。
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