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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
SMILES string
[Cl-].[Cl-].[N+H](CC[N+H](C)C)(C)C
InChI key
LZILUQBEPQWWKH-UHFFFAOYSA-N
General description
Associated Drug Substance: Clavulanate Potassium
Therapeutic Area: Antibiotics
Application
Features and Benefits
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.
Analysis Note
1 of 1
Dieser Artikel | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description Pharmaceutical Analytical Impurity (PAI) | description Pharmaceutical Analytical Impurity (PAI) | description BioReagent, Molecular Biology, ≥99% (GC) |
| application(s) pharmaceutical small molecule | application(s) pharmaceutical | application(s) pharmaceutical small molecule | application(s) - |
| format neat | format neat | format neat | format - |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade Molecular Biology |
| storage temp. -10 to -25°C | storage temp. 2-8°C | storage temp. -10 to -25°C | storage temp. - |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename - |
| agency USP | agency USP | agency USP | agency - |
Signalwort
Danger
Gefahrencodes
Hazard Classifications
Acute Tox. 3 Inhalation - Acute Tox. 4 Oral - Eye Dam. 1 - Skin Corr. 1B
Lagerklasse
6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
Was ist los?
WGK 3
Flammpunkt (°F)
Not applicable
Flammpunkt (°C)
Not applicable
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