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Merck
CN
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主要文件

PHR3611

Supelco

N-Nitrosomethylphenylamine (NMPA)

certified reference material, pharmaceutical secondary standard

别名:

N-Methyl-N-nitrosoaniline, N-Methyl-N-nitrosobenzenamine, N-Methyl-N-phenylnitrosamine, NMPA

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About This Item

经验公式(希尔记法):
C7H8N2O
CAS号:
分子量:
136.15
UNSPSC代码:
41116107
NACRES:
NA.24

等级

certified reference material
pharmaceutical secondary standard

质量水平

Agency

traceable to USP 1466607

表单

methanol solution

CofA

current certificate can be downloaded

包装

pkg of 1 mL

应用

pharmaceutical

储存温度

-10 to -25°C

SMILES字符串

N(N=O)(C)c1ccccc1

InChI

1S/C7H8N2O/c1-9(8-10)7-5-3-2-4-6-7/h2-6H,1H3

InChI key

MAXCWSIJKVASQC-UHFFFAOYSA-N

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一般描述

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.

应用

N-Nitrosomethylphenylamine (NMPA) pharmaceutical secondary reference standard is used for impurity analysis of NMPA in pharmaceutical formulations using supercriticalfluid chromatography (SFC).

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

分析说明

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

其他说明

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.

溶剂

说明

    1000 ug/mL solution in Methanol

象形图

Skull and crossbonesHealth hazard

警示用语:

Danger

危险声明

危险分类

Acute Tox. 3 Oral - Carc. 1B - Eye Irrit. 2

储存分类代码

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

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable


历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Analytical lifecycle management for comprehensive and universal nitrosamine analysis in various pharmaceutical formulations by supercritical fluid chromatography
Schmidtsdorff, S et al.
Journal of Pharmaceutical and Biomedical Analysis, 197, 113960-113960 (2021)

商品

Discover the efficient separation six nitrosamine impurities with high reproducibility and precise detection to ensure accurate analysis for regulatory compliance.

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>.

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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