PHR3607

N-Nitrosodiisopropylamine (NDIPA)

certified reference material, pharmaceutical secondary standard

• Sinónimos: N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP
• Fórmula empírica (notación de Hill): C₆H₁₄N₂O
• Número de CAS: 601-77-4
• Peso molecular: 130.19
• Número MDL: MFCD00015392
• Código UNSPSC: 41116107
• NACRES: NA.24

Propiedades

• grado: certified reference material; pharmaceutical secondary standard
• Nivel de calidad: 300
• Agency: traceable to USP 1466663
• Formulario: methanol solution
• CofA: current certificate can be downloaded
• envase: pkg of 1 mL
• aplicaciones: pharmaceutical
• temp. de almacenamiento: -10 to -25°C
• InChI: 1S/C6H14N2O/c1-5(2)8(7-9)6(3)4/h5-6H,1-4H3
• Clave InChI: AUIKJTGFPFLMFP-UHFFFAOYSA-N

Descripción

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-Nitrosodiisopropylamine (NDIPA) pharmaceutical secondary reference standard is used for determining NDIPA impurity in sartan pharmaceutical products using High-Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).

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 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.

Disolvente

1000 ug/mL solution in methanol

Información de seguridad

• Pictogramas: GHS08,GHS07
• Palabra de señalización: Danger
• Frases de peligro: H302,H350
• Consejos de prudencia: P202 - P264 - P280 - P301 + P312 - P308 + P313 - P405
• Clasificaciones de peligro: Acute Tox. 4 Oral - 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