grade
pharmaceutical primary standard (
)
API family
nifedipine
form
liquid
packaging
pkg of 1 mg
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecules)
format
neat
storage temp.
−20°C
SMILES string
N(N=O)(CC)CC
InChI
1S/C4H10N2O/c1-3-6(4-2)5-7/h3-4H2,1-2H3
InChI key
WBNQDOYYEUMPFS-UHFFFAOYSA-N
General description
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.
Application
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.
Analysis Note
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
此项目有
商品
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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。
An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.
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。
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.
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| 1466652-1ML | 04065265949750 |