PHR3609

N-Nitrosoethylisopropylamine (NEIPA / NIPEA)

certified reference material, pharmaceutical secondary standard

• Synonyme(s) : N-Ethyl-N-nitroso-2-propanamine, EIPNA, NEIPA
• Formule empirique (notation de Hill): C₅H₁₂N₂O
• Numéro CAS: 16339-04-1
• Poids moléculaire : 116.16
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• 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

Description

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

1000 ug/mL solution in methanol

Informations sur la sécurité

• Pictogrammes: GHS08,GHS07
• Mention d'avertissement: Danger
• Mentions de danger: H302,H350
• Conseils de prudence: P202 - P264 - P280 - P301 + P312 - P308 + P313 - P405
• 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)