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Merck

PHR2408

Supelco

N-Nitrosodiethylamine

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

N-Nitrosodiethylamine, Diethylnitrosamine

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About This Item

Fórmula lineal:
(C2H5)2NNO
Número de CAS:
Peso molecular:
102.14
Beilstein:
1744991
Número MDL:
Código UNSPSC:
41116107
NACRES:
NA.24
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grado

certified reference material
pharmaceutical secondary standard

Nivel de calidad

Agency

traceable to USP 1466652

Formulario

liquid

CofA

current certificate can be downloaded

envase

pkg of 1 g

bp

177 °C (lit.)

densidad

0.95 g/mL (lit.)

aplicaciones

pharmaceutical

temp. de almacenamiento

2-30°C

cadena SMILES

CCN(CC)N=O

InChI

1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3

Clave InChI

WBNQDOYYEUMPFS-UHFFFAOYSA-N

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Descripción general

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.

Aplicación

N-Nitrosodiethylamine (NDEA) pharmaceutical secondary referencestandard is used to determine NDEA impurity in:
  • Lisinopril API and its final product[1]
  • Sitagliptin and metformin hydrochlorideimmediate and extended-release formulations[2]
These Secondary Standards are qualified as Certified ReferenceMaterials. These are suitable for use in several analytical applicationsincluding but not limited to pharma release testing, pharma method developmentfor qualitative and quantitative analyses, food and beverage quality controltesting, and other calibration requirements.

Nota de análisis

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Otras notas

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Nota al pie de página

To see an example of a Certificate of Analysis for this material enter LRAC4356 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Productos recomendados

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Pictogramas

Skull and crossbonesHealth hazard

Palabra de señalización

Danger

Frases de peligro

Clasificaciones de peligro

Acute Tox. 3 Oral - Aquatic Chronic 3 - Carc. 1B

Código de clase de almacenamiento

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Clase de riesgo para el agua (WGK)

WGK 3

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable


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Certificados de análisis (COA)

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Visite la Librería de documentos

Development and Validation of an HPLC-FLD Method for the Determination of NDMA and NDEA Nitrosamines in Lisinopril Using Pre-Column Denitrosation and Derivatization Procedure
Tsanaktsidou, et al
Separations, 9, 347-347 (2022)
Development and validation of rapid ultra high performance liquid chromatography with tandem mass spectroscopic method for the quantification of N-nitrosodimethyl amine and N-nitrosodiethyl amine in sitagliptin and metformin hydrochloride immediate and extended-release formulations
Mallavarapu, et al.
Journal of Separation Science, 45, 3067-3081 (2022)

Artículos

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

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Contenido relacionado

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.

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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