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Key Documents

PHR3607

Supelco

N-Nitrosodiisopropylamine (NDIPA)

certified reference material, pharmaceutical secondary standard

Sinónimos:

N-Isopropyl-N-nitrosoisopropylamine, DIPNA, NDIP

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About This Item

Fórmula empírica (notación de Hill):
C6H14N2O
Número de CAS:
Peso molecular:
130.19
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to USP 1466663

form

methanol solution

CofA

current certificate can be downloaded

packaging

pkg of 1 mL

application(s)

pharmaceutical

storage temp.

-10 to -25°C

InChI

1S/C6H14N2O/c1-5(2)8(7-9)6(3)4/h5-6H,1-4H3

InChI key

AUIKJTGFPFLMFP-UHFFFAOYSA-N

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General description

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-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.

Analysis Note

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

Other Notes

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

Descripción

    1000 ug/mL solution in methanol

related product

Referencia del producto
Descripción
Precios

pictograms

Health hazardExclamation mark

signalword

Danger

hcodes

Hazard Classifications

Acute Tox. 4 Oral - Carc. 1B

Storage Class

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

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificados de análisis (COA)

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Visite la Librería de documentos

Investigation of Carcinogenic Impurities of N-Nitrosamines in Sartan Pharmaceutical Products Marketed in Brazil: Development and Validation of Method Based on High-Performance Liquid Chromatography-Tandem Mass Spectrometry
Monteiro, MA et al.
Journal of Pharmaceutical Sciences, 112, 1305-1314 (2023)

Artículos

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

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

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

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

Contenido relacionado

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.

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.

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.

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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