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安全信息

1466641

USP

N-Nitrosodibutylamine (NDBA)

United States Pharmacopeia (USP) Reference Standard

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别名:
N-Butyl-N-nitroso-1-butanamine
经验公式(希尔记法):
C8H18N2O
CAS号:
分子量:
158.24
UNSPSC代码:
41116107
NACRES:
NA.24

包装

pkg of 1 mg

制造商/商品名称

USP

应用

pharmaceutical (small molecules)

格式

neat

储存温度

−20°C

InChI

1S/C8H18N2O/c1-3-5-7-10(9-11)8-6-4-2/h3-8H2,1-2H3

InChI key

YGJHZCLPZAZIHH-UHFFFAOYSA-N

一般描述

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.

应用

N-Nitrosodibutylamine (NDBA) USP reference standard is intended for use only as specifically prescribed in the United States Pharmacopoeia.

It is also used to prepare standard, nitrosamine standards stock solution mixture, and sensitivity solutions to determine NDBA impurity in drug substances and drug products (valsartan, irbesartan, and losartan potassium etc.) by chromatography according to general chapter <1469> of United States Pharmacopeia.

分析说明

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.  

其他说明

Sales restrictions may apply.

警示用语:

Danger

危险分类

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

靶器官

Eyes,Central nervous system

WGK

WGK 2

闪点(°F)

49.5 °F

闪点(°C)

9.7 °C

法规信息

危险化学品

分析证书(COA)

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

商品

大致介绍亚硝胺杂质检测、全球法规以及在样品制备和分析中过滤器选型的主要注意事项。

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

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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