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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
aripiprazole
manufacturer/tradename
USP
mp
233-237 °C
application(s)
pharmaceutical
format
neat
storage temp.
2-8°C
SMILES string
Oc1ccc2CCC(=O)Nc2c1
InChI
1S/C9H9NO2/c11-7-3-1-6-2-4-9(12)10-8(6)5-7/h1,3,5,11H,2,4H2,(H,10,12)
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Dieser Artikel | |||
|---|---|---|---|
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical |
| format neat | format neat | format neat | format neat |
| agency USP | agency USP | agency USP | agency USP |
| API family aripiprazole | API family aripiprazole | API family aripiprazole | API family aripiprazole |
General description
USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.
Associated Drug Substance: Aripiprazole.
For more information about this PAI, visit here.
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
Other Notes
signalword
Warning
hcodes
Hazard Classifications
Acute Tox. 4 Oral - Skin Sens. 1
Lagerklasse
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
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Protokolle
Aripiprazole, an atypical antipsychotic, treats schizophrenia, bipolar disorder, and major depressive disorder.
Global Trade Item Number
| SKU | GTIN |
|---|---|
| 1A02550-25MG | 04065269107484 |
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