1A02780
USP
2,4,5-Trimethylketoprofen
Pharmaceutical Analytical Impurity (PAI)
Synonym(s):
((2RS)-2-[3-(2,4,5-Trimethylbenzoyl)phenyl]propanoic Acid)
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About This Item
grade
pharmaceutical analytical impurity (PAI)
Agency
USP
API family
ketoprofen
manufacturer/tradename
USP
application(s)
pharmaceutical
format
neat
storage temp.
−20°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: 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
Signal Word
Warning
Hazard Statements
Precautionary Statements
Hazard Classifications
Acute Tox. 4 Oral
Storage Class Code
11 - Combustible Solids
WGK
WGK 3
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Regulatory Information
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