Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf
PHR2407
N-Nitrosodiméthylamine (NDMA)
Pharmaceutical Secondary Standard; Certified Reference Material
Synonyme(s) :
N-nitrosodiméthylamine, Diméthylnitrosamine
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About This Item
Produits recommandés
Qualité
certified reference material
pharmaceutical secondary standard
Niveau de qualité
Agence
traceable to USP 1466674
Pression de vapeur
5 mmHg ( 20 °C)
Forme
liquid
CofA (certificat d'analyse)
current certificate can be downloaded
Conditionnement
pkg of 100 mg
Indice de réfraction
n20/D 1.437 (lit.)
pb
153 °C/774 mmHg (lit.)
Densité
1.01 g/mL (lit.)
Application(s)
pharmaceutical
Température de stockage
2-8°C
Chaîne SMILES
CN(C)N=O
InChI
1S/C2H6N2O/c1-4(2)3-5/h1-2H3
Clé InChI
UMFJAHHVKNCGLG-UHFFFAOYSA-N
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Description générale
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
Actions biochimiques/physiologiques
Autres remarques
Note de bas de page
Mention d'avertissement
Danger
Mentions de danger
Conseils de prudence
Classification des risques
Acute Tox. 1 Inhalation - Acute Tox. 2 Oral - Aquatic Chronic 2 - Carc. 1B - STOT RE 1
Organes cibles
Liver
Code de la classe de stockage
6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
Classe de danger pour l'eau (WGK)
WGK 3
Point d'éclair (°F)
141.8 °F - closed cup
Point d'éclair (°C)
61.0 °C - closed cup
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Certificats d'analyse (COA)
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Articles
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
Contenu apparenté
Accurately detect and quantify trace nitrosamines (NDMA, NDEA, NEIPA, NDIPA, NDBA, etc.) in pharmaceutical drugs using our complete product portfolio and application guides for LC-MS and GC-MS. Order high-quality reference standards, columns, filters & more.
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How is shipping temperature determined? And how is it related to the product storage temperature?
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How can I determine the shelf life / expiration / retest date of this product?
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If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/449/386/product-dating-information-mk.pdfHelpful?
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I bought the PHR2407-100 mg product; however, I can not find information about the liquid in which it was dissolved. Can you please give me that information?
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This product is supplied as a neat or pure liquid that has not been diluted in a solvent or buffer. This compound has a density of 1.01 g/mL.
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