PHR2407
N-Nitrosodimethylamine (NDMA)
Pharmaceutical Secondary Standard; Certified Reference Material
Synonym(s):
N-Nitrosodimethylamine, NDMA, Dimethylnitrosamine
About This Item
Recommended Products
grade
certified reference material
pharmaceutical secondary standard
Quality Level
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.)
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This Item | OGS538 | OGS552 | OGS550 |
|---|---|---|---|
| bacteria selection kanamycin | bacteria selection kanamycin | bacteria selection kanamycin | bacteria selection kanamycin |
| promoter Promoter name: TEF1 | promoter Promoter name: TEF1 | promoter Promoter name: TEF1 | promoter Promoter name: TEF1 |
| yeast selection uracil | yeast selection uracil | yeast selection uracil | yeast selection uracil |
| mol wt size 7127 bp | mol wt size 7023 bp | mol wt size 5892 bp | mol wt size 8284 bp |
| form buffered aqueous solution | form buffered aqueous solution | form buffered aqueous solution | form buffered aqueous solution |
General description
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
- 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
Footnote
Signal Word
Danger
Hazard Statements
Precautionary Statements
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
Regulatory Information
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Certificates of Analysis (COA)
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Articles
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
Related Content
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