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Informazioni su questo articolo
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
aripiprazole
manufacturer/tradename
USP
application(s)
pharmaceutical
format
neat
storage temp.
2-8°C
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
1 of 1
Questo articolo | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description Pharmaceutical Analytical Impurity (PAI) | description Pharmaceutical Analytical Impurity (PAI) | description United States Pharmacopeia (USP) Reference Standard |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical primary standard |
| format neat | format neat | format neat | format neat |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical (small molecule) |
| storage temp. 2-8°C | storage temp. 2-8°C | storage temp. 2-8°C | storage temp. 2-8°C |
| API family aripiprazole | API family aripiprazole | API family aripiprazole | API family aripiprazole |
Parola di avvertenza
Warning
Codici di pericolo
Avvertenze di sicurezza
Hazard Classifications
Acute Tox. 4 Oral - Aquatic Chronic 4
Classe di stoccaggio
11 - Combustible Solids
Che succede?
WGK 1
Punto di infiammabilità (°F)
Not applicable
Punto di infiammabilità (°C)
Not applicable
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