PHR2407
N-Nitrosodimethylamine (NDMA)
Pharmaceutical Secondary Standard; Certified Reference Material
Synonym(s):
N-Nitrosodimethylamine, NDMA, Dimethylnitrosamine
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About This Item
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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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.
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
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
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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