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Merck
CN

PHR2408

N-亚硝基二乙胺 (NDEA)

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

N-亚硝基二乙胺, 二乙基亚硝胺

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线性分子式:
(C2H5)2NNO
化学文摘社编号:
55-18-5
分子量:
102.14
NACRES:
NA.24
UNSPSC Code:
41116107
Beilstein/REAXYS Number:
1744991
MDL number:
MFCD00013890

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产品名称

N-亚硝基二乙胺 (NDEA), Pharmaceutical Secondary Standard; Certified Reference Material

SMILES string

CCN(CC)N=O

InChI

1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3

InChI key

WBNQDOYYEUMPFS-UHFFFAOYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1466652

form

liquid

CofA

current certificate can be downloaded

packaging

pkg of 1 g

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

bp

177 °C (lit.)

density

0.95 g/mL (lit.)

application(s)

pharmaceutical

storage temp.

2-30°C

Quality Level

300

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Analysis Note

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

Application

N-Nitrosodiethylamine (NDEA) pharmaceutical secondary referencestandard is used to determine NDEA impurity in:
  • Lisinopril API and its final product
  • Sitagliptin and metformin hydrochlorideimmediate and extended-release formulations
These Secondary Standards are qualified as Certified ReferenceMaterials. These are suitable for use in several analytical applicationsincluding but not limited to pharma release testing, pharma method developmentfor qualitative and quantitative analyses, food and beverage quality controltesting, and other calibration requirements.

General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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.
To see an example of a Certificate of Analysis for this material enter LRAC4356 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Skull and crossbonesHealth hazard
GHS06,GHS08

signalword

Danger

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Chronic 3 - Carc. 1B

存储类别

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

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Development and Validation of an HPLC-FLD Method for the Determination of NDMA and NDEA Nitrosamines in Lisinopril Using Pre-Column Denitrosation and Derivatization Procedure
Tsanaktsidou, et al
Separations, 9, 347-347 (2022)
Development and validation of rapid ultra high performance liquid chromatography with tandem mass spectroscopic method for the quantification of N-nitrosodimethyl amine and N-nitrosodiethyl amine in sitagliptin and metformin hydrochloride immediate and extended-release formulations
Mallavarapu, et al.
Journal of Separation Science, 45, 3067-3081 (2022)

商品

N-Nitrosamines Determination in Valsartan

GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.

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.

缬沙坦中的N-亚硝胺测定

亚硝胺经证是沙坦家族活性药物成分 (API) 中的一种严重污染物。本文介绍了一种根据美国 FDA 指南测定缬沙坦片中亚硝胺含量的 GC-MS 方法，适用于药品质量控制。

相关内容

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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