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1466652

USP

N-Nitrosodiethylamine (NDEA)

United States Pharmacopeia (USP) Reference Standard

同義詞:

N-Ethyl-N-nitrosoethanamine, NDEA

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About This Item

經驗公式(希爾表示法):
C4H10N2O
CAS號碼:
分子量::
102.14
分類程式碼代碼:
41116107
NACRES:
NA.24

包裝

pkg of 1 mg

製造商/商標名

USP

應用

pharmaceutical (small molecules)

格式

neat

儲存溫度

−20°C

InChI

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

InChI 密鑰

WBNQDOYYEUMPFS-UHFFFAOYSA-N

一般說明

This product is provided as delivered and specified by the USP Pharmacopoeia. For further information and support, including certificate/ product information sheets, please go to the website of the issuing Pharmacopoeia.

應用

N-Nitrosodiethylamine (NDEA) USP reference standard is intended for use only as specificallyprescribed in the United States Pharmacopoeia.

It is also used to prepare standard, standard stock, nitrosamineRS stock, Nitrosamine standards stock solution mixture, and sensitivity stocksolutions to determine NDEA impurity in drug substances and drug products(valsartan, irbesartan, and losartan potassium etc.) by chromatography methodaccording to the general chapter <1469> of United States Pharmacopeia.

分析報告

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

其他說明

Sales restrictions may apply.

訊號詞

Danger

危險分類

Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1

標靶器官

Eyes,Central nervous system

儲存類別代碼

3 - Flammable liquids

水污染物質分類(WGK)

WGK 3

閃點(°F)

49.5 °F

閃點(°C)

9.7 °C


分析證明 (COA)

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?1469? NITROSAMINE IMPURITIES
United States Pharmacopeia, 46(5) (2021)

文章

An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.

概述亞硝胺雜質測試、全球法規,以及樣品製備和分析過濾器選擇的主要考慮因素。

This application note describes the LC-MS-based quantitative analysis of known nitrosamine impurities following procedures 1 and 3 as given in USP general chapter <1469>.

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。

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相關內容

Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.

使用我們完整的 LC-MS 和 GC-MS 產品組合和應用指南,準確檢測和量化藥品中的痕量亞硝胺(NDMA、NDEA、NEIPA、NDIPA、NDBA 等)。訂購高品質參考標準、色譜柱、過濾器等。

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.

我們的科學家團隊在所有研究領域都有豐富的經驗,包括生命科學、材料科學、化學合成、色譜、分析等.

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