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About This Item
grade
pharmaceutical analytical impurity (PAI)
agency
USP
manufacturer/tradename
USP
mp
145-148 °C (lit.)
application(s)
pharmaceutical
format
neat
storage temp.
2-8°C
SMILES string
CC(C#N)c1cccc(c1)C(O)=O
InChI
1S/C10H9NO2/c1-7(6-11)8-3-2-4-9(5-8)10(12)13/h2-5,7H,1H3,(H,12,13)
InChI key
IRYIYPWRXROPSX-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.
Associated Drug Substance: Ketoprofen.
For more information about this PAI, visit here.
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
This Item | |||
|---|---|---|---|
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename - | manufacturer/tradename USP |
| grade pharmaceutical analytical impurity (PAI) | grade - | grade certified reference material, pharmaceutical secondary standard | grade pharmaceutical analytical impurity (PAI) |
| application(s) pharmaceutical | application(s) pharmaceutical (small molecule) | application(s) - | application(s) pharmaceutical |
| format neat | format neat | format - | format neat |
| storage temp. 2-8°C | storage temp. 2-8°C | storage temp. 2-8°C | storage temp. 2-8°C |
| mp 145-148 °C (lit.) | mp - | mp - | mp - |
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signalword
Danger
hcodes
Hazard Classifications
Acute Tox. 4 Oral - Eye Dam. 1 - Skin Sens. 1
Storage Class
11 - Combustible Solids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
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Global Trade Item Number
| SKU | GTIN |
|---|---|
| 1A02750-25MG | 04065269096825 |