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A propos de cet article
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
bosentan
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
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: Bosentan
Therapeutic Area: Pulmonary
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
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Cet article | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description Pharmaceutical Analytical Impurity (PAI) | description United States Pharmacopeia (USP) Reference Standard | description Pharmaceutical Analytical Impurity (PAI) |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical primary standard | grade pharmaceutical analytical impurity (PAI) |
| 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 |
| storage temp. 2-8°C | storage temp. -10 to -25°C | storage temp. 2-8°C | storage temp. -10 to -25°C |
Codes de danger
Mentions de précaution
Hazard Classifications
Aquatic Chronic 3
Classe de stockage
11 - Combustible Solids
WGK
WGK 3
Point d'éclair (°F)
Not applicable
Point d'éclair (°C)
Not applicable
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