PHR3609

N-Nitrosoethylisopropylamine (NEIPA / NIPEA)

certified reference material, pharmaceutical secondary standard

• Sinônimo(s): N-Ethyl-N-nitroso-2-propanamine, EIPNA, NEIPA
• Fórmula empírica (Notação de Hill): C₅H₁₂N₂O
• Número CAS: 16339-04-1
• Peso molecular: 116.16
• Código UNSPSC: 41116107
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to USP 1466685
• forma: methanol solution
• Certificado de análise (CofA): current certificate can be downloaded
• embalagem: pkg of 1 mL
• aplicação(ões): pharmaceutical
• temperatura de armazenamento: -10 to -25°C
• InChI: 1S/C5H12N2O/c1-4-7(6-8)5(2)3/h5H,4H2,1-3H3
• chave InChI: VGGZTNNNXAUZLB-UHFFFAOYSA-N

Descrição

Descrição geral

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.

Aplicação

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.

Nota de análise

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

Outras 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.

Solvente

1000 ug/mL solution in methanol

Informações de segurança

• Pictogramas: GHS08,GHS07
• Palavra indicadora: Danger
• Frases de perigo: H302,H350
• Declarações de precaução: P202 - P264 - P280 - P301 + P312 - P308 + P313 - P405
• Classificações de perigo: Acute Tox. 4 Oral - Carc. 1B
• Código de classe de armazenamento: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): 150.6 °F - (calculated)
• Ponto de fulgor (°C): 65.9 °C - (calculated)