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PHR2407

Supelco

N-Nitrosodimethylamine

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

N-Nitrosodimethylamine, NDMA, Dimethylnitrosamine

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100 MG
$191.58

$191.58

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100 MG
$191.58

About This Item

Fórmula lineal:
(CH3)2NNO
Número de CAS:
62-75-9
Peso molecular:
74.08
Número MDL:
MFCD00002053
Código UNSPSC:
41116107
NACRES:
NA.24

$191.58

Precio de catálogo$206.00Ahorre 7 %
Web-Only Promotion

Disponible para envío el07 de abril de 2025Detalles

Solicitar un pedido a granel

grado

certified reference material
pharmaceutical secondary standard

Nivel de calidad

300

Agency

traceable to USP 1466674

presión de vapor

5 mmHg ( 20 °C)

Formulario

liquid

CofA

current certificate can be downloaded

envase

pkg of 100 mg

índice de refracción

n20/D 1.437 (lit.)

bp

153 °C/774 mmHg (lit.)

densidad

1.01 g/mL (lit.)

aplicaciones

pharmaceutical

temp. de almacenamiento

2-8°C

cadena SMILES

CN(C)N=O

InChI

1S/C2H6N2O/c1-4(2)3-5/h1-2H3

Clave InChI

UMFJAHHVKNCGLG-UHFFFAOYSA-N

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Descripción general

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.

Aplicación

N-Nitrosodimethylamine CRM may also find uses as given below:

  • 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

Acciones bioquímicas o fisiológicas

Induces gastric, liver, kidney and lung cancer in mice and rats.

Otras notas

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.

Nota al pie de página

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.

Palabra de señalización

Danger

Clasificaciones de peligro

Acute Tox. 1 Inhalation - Acute Tox. 2 Oral - Aquatic Chronic 2 - Carc. 1B - STOT RE 1

Órganos de actuación

Liver

Código de clase de almacenamiento

6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials

Clase de riesgo para el agua (WGK)

WGK 3

Punto de inflamabilidad (°F)

141.8 °F - closed cup

Punto de inflamabilidad (°C)

61.0 °C - closed cup

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Certificados de análisis (COA)

Lot/Batch Number

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Artículos

N-Nitrosamines Determination in Valsartan

GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.

Contenido relacionado

Nitrosamines in Pharmaceuticals

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.

Questions

1–3 of 3 Questions  

  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer

    1. 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.pdf

      Helpful?

  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer

    1. 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

      Helpful?

  3. 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?

    1 answer

    1. 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.

      Helpful?

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