1466652
USP
N-Nitrosodiethylamine (NDEA)
United States Pharmacopeia (USP) Reference Standard
别名:
N-Ethyl-N-nitrosoethanamine, NDEA
等级
pharmaceutical primary standard (
)
API类
nifedipine
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
neat
储存温度
−20°C
SMILES字符串
N(N=O)(CC)CC
InChI
1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3
InChI key
WBNQDOYYEUMPFS-UHFFFAOYSA-N
一般描述
N-Nitrosodiethylamine is a carcinogenic compound that is strictly regulated within the biologics and pharmaceutical industries. Although not used as an ingredient, its presence is monitored in biologic products, as trace amounts can be toxic. NDEA is studied extensively for its potential health risks, and its detection is critical to ensuring the safety and regulatory compliance of biologic formulations.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
应用
It is also used to prepare standard, standard stock, nitrosamineRS stock, Nitrosamine standards stock solution mixture, and sensitivity stocksolutions to determine NDEA impurity in drug substances and drug products(valsartan, irbesartan, and losartan potassium etc.) by chromatography methodaccording to the general chapter <1469> of United States Pharmacopeia.
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
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