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Informacje o tej pozycji
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
lenalidomide
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
General description
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
Ta pozycja | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description Pharmaceutical Analytical Impurity (PAI) | description Pharmaceutical Analytical Impurity (PAI) | description United States Pharmacopeia (USP) Reference Standard |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical small molecule |
| format neat | format neat | format neat | format neat |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) |
| storage temp. -10 to -25°C | storage temp. -10 to -25°C | storage temp. -10 to -25°C | storage temp. 2-30°C |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| API family lenalidomide | API family lenalidomide | API family lenalidomide | API family - |
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Słowo ostrzegawcze
Warning
Kody zagrożeń
Hazard Classifications
Repr. 2 - STOT RE 2
Narządy docelowe
Blood
Klasa składowania
11 - Combustible Solids
WGK
WGK 3
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