产品名称
N -亚硝基二甲胺(NDMA), United States Pharmacopeia (USP) Reference Standard
SMILES string
N(N=O)(C)C
InChI
1S/C2H6N2O/c1-4(2)3-5/h1-2H3
InChI key
UMFJAHHVKNCGLG-UHFFFAOYSA-N
grade
pharmaceutical primary standard (
)
form
liquid
packaging
pkg of 1 mg
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecules)
format
single component solution (solution in methanol)
storage temp.
−20°C
Analysis Note
Application
它还用于制备标准品、标准储备液、亚硝胺RS储备液、亚硝胺标准品储备液混合物和灵敏度储备液，以通过美国药典总则第 〈1469〉 章的色谱法测定原料药和药品（缬沙坦、厄贝沙坦和氯沙坦钾等）中的NDMA杂质。
Other Notes
signalword
Danger
Hazard Classifications
Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1
target_organs
Eyes,Central nervous system
存储类别
3 - Flammable liquids
wgk
WGK 3
flash_point_f
49.5 °F
flash_point_c
9.7 °C
法规信息
商品
An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
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>.
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。
相关内容
提供适用USP-NF各论的全面标化的一级标准物质，可用于检验药物成分和剂型、药用辅料、食品和膳食补充剂。
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.
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.
我们的科学家团队拥有各种研究领域经验，包括生命科学、材料科学、化学合成、色谱、分析及许多其他领域.
联系客户支持