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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
citalopram
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: Escitalopram
Therapeutic Area: Psychiatrics.
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
Dieser Artikel | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description United States Pharmacopeia (USP) Reference Standard | description United States Pharmacopeia (USP) Reference Standard | description British Pharmacopoeia (BP) Reference Standard |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical primary standard | grade pharmaceutical primary standard | grade pharmaceutical primary standard |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename BP |
| application(s) pharmaceutical | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical |
| format neat | format neat | format neat | format mixture |
| storage temp. 2-8°C | storage temp. - | storage temp. - | storage temp. 2-8°C |
| API family citalopram | API family citalopram | API family citalopram | API family citalopram |
Lagerklasse
11 - Combustible Solids
Was ist los?
WGK 3
Flammpunkt (°F)
Not applicable
Flammpunkt (°C)
Not applicable
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