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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
manufacturer/tradename
USP
application(s)
pharmaceutical
format
neat
storage temp.
2-8°C
SMILES string
O=C(C)c1ccc(cc1)C
InChI
1S/C9H10O/c1-7-3-5-9(6-4-7)8(2)10/h3-6H,1-2H3
InChI key
GNKZMNRKLCTJAY-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: Celecoxib
Therapeutic Area: Analgesics
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
Dieser Artikel | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland | description ≥95%, FCC, FG | description for synthesis |
| grade pharmaceutical analytical impurity (PAI) | grade certified reference material, TraceCERT® | grade FG, Halal, Kosher | grade - |
| manufacturer/tradename USP | manufacturer/tradename Manufactured by: Sigma-Aldrich Production GmbH, Switzerland | manufacturer/tradename - | manufacturer/tradename - |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) flavors and fragrances | application(s) - |
| format neat | format - | format - | format - |
| agency USP | agency (Not traceable to any primary pharmacopeia standard) | agency meets purity specifications of JECFA | agency - |
| storage temp. 2-8°C | storage temp. −20°C | storage temp. - | storage temp. 2-30°C |
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signalword
Warning
hcodes
Hazard Classifications
Acute Tox. 4 Oral - Skin Irrit. 2
Lagerklasse
10 - Combustible liquids
wgk
WGK 1
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