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PHR3609

Supelco

N-Nitrosoethylisopropylamine (NEIPA / NIPEA)

certified reference material, pharmaceutical secondary standard

Synonyme(s) :

N-Ethyl-N-nitroso-2-propanamine, EIPNA, NEIPA

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About This Item

Formule empirique (notation de Hill):
C5H12N2O
Numéro CAS:
16339-04-1
Poids moléculaire :
116.16
Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

300

Agence

traceable to USP 1466685

Forme

methanol solution

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 1 mL

Application(s)

pharmaceutical

Température de stockage

-10 to -25°C

InChI

1S/C5H12N2O/c1-4-7(6-8)5(2)3/h5H,4H2,1-3H3

Clé InChI

VGGZTNNNXAUZLB-UHFFFAOYSA-N

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Catégories apparentées

Description générale

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.

Application

N-Nitrosoethylisopropylamine pharmaceutical secondary reference standard can be used for the determination of NEIPA impurity in valsartan products, via gas chromatography-tandem mass spectrometry.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Remarque sur l'analyse

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

Autres remarques

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.

Solvant

Description
    1000 ug/mL solution in methanol

Produit(s) apparenté(s)

Réf. du produit
Description
Tarif

Pictogrammes

Health hazardExclamation mark
GHS08,GHS07

Mention d'avertissement

Danger

Mentions de danger

H302,H350

Classification des risques

Acute Tox. 4 Oral - Carc. 1B

Code de la classe de stockage

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

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

150.6 °F - (calculated)

Point d'éclair (°C)

65.9 °C - (calculated)

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Certificats d'analyse (COA)

Lot/Batch Number
LRAD8749
LRAD0175
LRAD0175

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

Development of GC-MS/MS Method for Simultaneous Estimation of Four Nitrosoamine Genotoxic Impurities in Valsartan
Rao T, et al.
Turkish Journal of Pharmaceutical Sciences, 19, 455-455 (2022)

Articles

HPLC Separation of Nitrosamines with Supel Carbon LC

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

Contenu apparenté

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.

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