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Dear Customer:

The current international situation is complex and volatile, and uncertain tariff policies may potentially impact our product prices. Given these uncertainties, we value your understanding regarding order-related matters.

If you decide to place an order during this period, we reserve the right to adjust the price based on the evolving situation. We understand that market changes may cause inconvenience. We will negotiate with you if there’s a significant price fluctuation due to tariff policy changes before the order’s actual delivery, and in such cases we may adjust or cancel the order as necessary.

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主要文件

安全信息

PHR2407

Supelco

N-亚硝基二甲胺

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

二甲基亚硝胺

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选择尺寸

25 ML
¥226.18
1 L
¥971.51
4 L
¥2,281.90

¥226.18


国内现货,预计发货时间2025年4月27日详情


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25 ML
¥226.18
1 L
¥971.51
4 L
¥2,281.90

About This Item

线性分子式:
(CH3)2NNO
CAS号:
分子量:
74.08
MDL编号:
UNSPSC代码:
41116107
NACRES:
NA.24

¥226.18


国内现货,预计发货时间2025年4月27日详情


获取大包装报价

等级

certified reference material
pharmaceutical secondary standard

质量水平

Agency

traceable to USP 1466674

蒸汽压

5 mmHg ( 20 °C)

表单

liquid

CofA

current certificate can be downloaded

包装

pkg of 100 mg

折射率

n20/D 1.437 (lit.)

沸点

153 °C/774 mmHg (lit.)

密度

1.01 g/mL (lit.)

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此商品
27267U27185U27088U
volume

4 mL

volume

2 mL

volume

40 mL

volume

15 mL

feature

closure type screw top vial

feature

closure type screw top vial

feature

closure type screw top vial

feature

closure type screw top vial

fitting

thread for 13-425

fitting

thread for 10-425

fitting

thread for 24-400

fitting

thread for 18-400

material

amber glass vial

material

amber glass vial

material

amber glass vial

material

amber glass vial

packaging

pkg of 100 ea

packaging

pkg of 100 ea

packaging

pkg of 100 ea

packaging

pkg of 100 ea

O.D. × H × I.D.

15 mm × 45 mm × 8 mm

O.D. × H × I.D.

12 mm × 32 mm × 6 mm

O.D. × H × I.D.

29 mm × 82 mm × 17 mm

O.D. × H × I.D.

21 mm × 70 mm × 12 mm

一般描述

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. It is analyzed using GMP validated instruments as per pharmacopeia monograph methods and is traceable to Unites States Pharmacopeia (USP), European Pharmacopeia (EP), and British Pharmacopeia (BP) primary standards, wherever applicable.

It is provided with a comprehensive certificate of analysis (CoA) containing a certified purity value, calculated by the mass balance approach. All information regarding the use of this CRM can be found on the certificate of analysis.N-Nitrosodimethylamine (NDMA) is a nitrosamine that occurs as an impurity in sartan angiotensin II receptor blocker drugs.

应用

N-Nitrosodimethylamine CRM may also find uses as given below:

  • Determination of N-Nitrosodimethylamine (NDMA) as an impurity in four valsartan APIs and tablets by high-performance liquid chromatography (HPLC)
  • Quantitative analysis of NDMA in valsartan pharmaceutical formulations by capillary electrophoresis-nanospray-mass spectrometry
  • Simultaneous determination of N-nitrosodimethylamine and N-nitrosomethylethylamine in drug substances and products containing sartans, ranitidine, and metformin by solid-phase extraction (SPE) and gas chromatography-tandem mass spectrometry (GC-MS/MS)
  • Analysis of NDMA in the olmesartan API and tablets by high-performance liquid chromatography-mass spectrometry (HPLC-MS)
  • Development and validation of an HPLC-MS/MS method for separation and quantification of NDMA impurity for quality control of ranitidine products

生化/生理作用

诱发大、小鼠出现胃癌、肝癌、肾癌和肺癌。

其他说明

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.

附注

To see an example of a Certificate of Analysis for this material enter LRAC4355 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

警示用语:

Danger

危险分类

Acute Tox. 1 Inhalation - Acute Tox. 2 Oral - Aquatic Chronic 2 - Carc. 1B - STOT RE 1

靶器官

Liver

储存分类代码

6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials

WGK

WGK 3

闪点(°F)

141.8 °F - closed cup

闪点(°C)

61.0 °C - closed cup

法规信息

非剧毒-急性毒性1
  • 技术规格说明书

  • 历史批次信息供参考:

    分析证书(COA)

    Lot/Batch Number

    It looks like we've run into a problem, but you can still download Certificates of Analysis from our 文件 section.

    如需帮助,请联系 客户支持

    已有该产品?

    在文件库中查找您最近购买产品的文档。

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    商品

    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。

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

    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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