1466674
USP
N -亚硝基二甲胺(NDMA)
United States Pharmacopeia (USP) Reference Standard
别名:
N -甲基- N -亚硝基甲胺, NDMA
等级
pharmaceutical primary standard (
)
表单
liquid
包装
pkg of 1 mg
制造商/商品名称
USP
应用
USP Biologics
pharmaceutical (small molecules)
包装形式
single component solution (solution in methanol)
储存温度
−20°C
SMILES字符串
N(N=O)(C)C
InChI
1S/C2H6N2O/c1-4(2)3-5/h1-2H3
InChI key
UMFJAHHVKNCGLG-UHFFFAOYSA-N
应用
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。
分析说明
其他说明
警示用语：
Danger
危险分类
Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Carc. 1B - Flam. Liq. 2 - STOT SE 1
靶器官
Eyes,Central nervous system
储存分类代码
3 - Flammable liquids
WGK
WGK 3
闪点(°F)
49.5 °F
闪点(°C)
9.7 °C
法规信息
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>.
GC-MS method detects nitrosamines in Valsartan tablets, meeting US FDA guidelines for pharmaceutical quality control.
相关内容
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.
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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