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Informazioni su questo articolo
grade
pharmaceutical analytical impurity (PAI)
agency
USP
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
SMILES string
N1(CCN(CC1)c2ncccn2)N=O
InChI
1S/C8H11N5O/c14-11-13-6-4-12(5-7-13)8-9-2-1-3-10-8/h1-3H,4-7H2
InChI key
NWSVVDNGQXGGIC-UHFFFAOYSA-N
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.
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
Questo articolo | |||
|---|---|---|---|
| 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 small molecule | application(s) pharmaceutical small molecule | application(s) pharmaceutical small molecule | 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 USP Analytical Reference Materials (ARMs) |
| storage temp. -10 to -25°C | storage temp. -10 to -25°C | storage temp. 2-30°C | storage temp. 2-8°C |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| agency USP | agency USP | agency USP | agency USP |
Classe di stoccaggio
11 - Combustible Solids
Punto di infiammabilità (°F)
Not applicable
Punto di infiammabilità (°C)
Not applicable
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