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Merck

PHR2408

Supelco

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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About This Item

线性分子式:
(C2H5)2NNO
CAS号:
分子量:
102.14
Beilstein:
1744991
MDL號碼:
分類程式碼代碼:
41116107
NACRES:
NA.24

等級

certified reference material
pharmaceutical secondary standard

品質等級

agency

traceable to USP 1466652

形狀

liquid

CofA

current certificate can be downloaded

包裝

pkg of 1 g

bp

177 °C (lit.)

密度

0.95 g/mL (lit.)

應用

pharmaceutical

儲存溫度

2-30°C

SMILES 字串

CCN(CC)N=O

InChI

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

InChI 密鑰

WBNQDOYYEUMPFS-UHFFFAOYSA-N

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一般說明

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.

應用

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.

分析報告

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

其他說明

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.

腳註

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.

推薦產品

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.

象形圖

Skull and crossbonesHealth hazard

訊號詞

Danger

危險聲明

危險分類

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

儲存類別代碼

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

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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分析证书(COA)

Lot/Batch Number

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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)
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)

商品

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.

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相关内容

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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