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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
abiraterone
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: Abiraterone Acetate
Therapeutic Area: Oncology
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 United States Pharmacopeia (USP) Reference Standard | description Pharmaceutical Secondary Standard; Certified Reference Material |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical primary standard | grade certified reference material, pharmaceutical secondary standard |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename - |
| application(s) pharmaceutical small molecule | application(s) pharmaceutical small molecule | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical small molecule |
| format neat | format neat | format neat | format - |
| API family abiraterone | API family abiraterone | API family abiraterone | API family abiraterone |
| storage temp. 2-8°C | storage temp. 2-8°C | storage temp. - | storage temp. 2-30°C |
Signalwort
Danger
Gefahrencodes
Sicherheitshinweise
Hazard Classifications
Aquatic Chronic 1 - Repr. 1B - STOT RE 2
Zielorgane
Endocrine system
Lagerklasse
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
Was ist los?
WGK 3
Flammpunkt (°F)
Not applicable
Flammpunkt (°C)
Not applicable
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