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PLN 3,070.00
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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
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1 of 4
This Item | |||
|---|---|---|---|
| application(s) pharmaceutical (small molecules) | application(s) pharmaceutical | application(s) pharmaceutical | application(s) cleaning products |
| format neat | format - | format - | format neat |
| storage temp. −20°C | storage temp. 2-30°C | storage temp. 2-8°C | storage temp. 2-30°C |
| packaging pkg of 1 mg | packaging pkg of 1 g | packaging - | packaging ampule of 1000 mg |
| manufacturer/tradename USP | manufacturer/tradename - | manufacturer/tradename EDQM | manufacturer/tradename - |
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
Storage Class
3 - Flammable liquids
wgk
WGK 3
flash_point_f
49.5 °F
flash_point_c
9.7 °C
Regulatory Listings
Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.
67-56-1
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Articles
Niniejsza nota aplikacyjna opisuje opartą na LC-MS analizę ilościową znanych zanieczyszczeń nitrozoaminowych zgodnie z procedurami 1 i 3 podanymi w rozdziale ogólnym USP <1469>.
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>.
Related Content
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.
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.
Zamów spośród szerokiej gamy wysoce scharakteryzowanych podstawowych referencyjnych materiałów wzorcowych do stosowania z monografiami USP-NF do testowania substancji leczniczych i postaci dawkowania, farmaceutycznych substancji pomocniczych, składników żywności i suplementów diety.
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.
Global Trade Item Number
| SKU | GTIN |
|---|---|
| 1466652-1ML | 04065265949750 |
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