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Informacje o tej pozycji
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
tacrolimus
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 United States Pharmacopeia (USP) Reference Standard | description Pharmaceutical Secondary Standard; Certified Reference Material | description United States Pharmacopeia (USP) Reference Standard |
| 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 - | format neat |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical primary standard | grade certified reference material, pharmaceutical secondary standard | grade pharmaceutical primary standard |
| storage temp. -10 to -25°C | storage temp. - | storage temp. -10 to -25°C | storage temp. - |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename - | manufacturer/tradename USP |
| API family tacrolimus | API family tacrolimus | API family tacrolimus | API family tacrolimus |
Słowo ostrzegawcze
Danger
Kody zagrożeń
Hazard Classifications
Acute Tox. 3 Oral - Eye Irrit. 2 - Repr. 2 - STOT RE 2
Klasa składowania
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
Co się dzieje?
WGK 3
Temperatura zapłonu (°F)
Not applicable
Temperatura zapłonu (°C)
Not applicable
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