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PHR2408

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N-Nitrosodiethylamin (NDEA)

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(e):

N-Nitrosodiethylamin, Diethylnitrosamin

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About This Item

Lineare Formel:
(C2H5)2NNO
CAS-Nummer:
Molekulargewicht:
102.14
Beilstein:
1744991
MDL-Nummer:
UNSPSC-Code:
41116107
NACRES:
NA.24

Qualität

certified reference material
pharmaceutical secondary standard

Qualitätsniveau

Agentur

traceable to USP 1466652

Form

liquid

Analysenzertifikat (CofA)

current certificate can be downloaded

Verpackung

pkg of 1 g

bp

177 °C (lit.)

Dichte

0.95 g/mL (lit.)

Anwendung(en)

pharmaceutical

Lagertemp.

2-30°C

SMILES String

CCN(CC)N=O

InChI

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

InChIKey

WBNQDOYYEUMPFS-UHFFFAOYSA-N

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Allgemeine Beschreibung

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.

Anwendung

N-Nitrosodiethylamine (NDEA) pharmaceutical secondary referencestandard is used to determine NDEA impurity in:
  • Lisinopril API and its final product
  • Sitagliptin and metformin hydrochlorideimmediate and extended-release formulations
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.

Hinweis zur Analyse

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

Sonstige Hinweise

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.

Fußnote

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.

Empfohlene Produkte

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.

Piktogramme

Skull and crossbonesHealth hazard

Signalwort

Danger

Gefahreneinstufungen

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

Lagerklassenschlüssel

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

WGK

WGK 3

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable


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Analysenzertifikate (COA)

Lot/Batch Number

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In der Dokumentenbibliothek finden Sie die Dokumentation zu den Produkten, die Sie kürzlich erworben haben.

Die Dokumentenbibliothek aufrufen

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)
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)

Artikel

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

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

Verwandter Inhalt

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.

Unser Team von Wissenschaftlern verfügt über Erfahrung in allen Forschungsbereichen einschließlich Life Science, Materialwissenschaften, chemischer Synthese, Chromatographie, Analytik und vielen mehr..

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