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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
clopidogrel
manufacturer/tradename
USP
application(s)
pharmaceutical
format
neat
storage temp.
2-8°C
SMILES string
S1C2CCN(CC2=CC1=O)C(c3c(cccc3)Cl)C(=O)OC
InChI
1S/C16H16ClNO3S/c1-21-16(20)15(11-4-2-3-5-12(11)17)18-7-6-13-10(9-18)8-14(19)22-13/h2-5,8,13,15H,6-7,9H2,1H3
InChI key
JBSAZVIMJUOBNB-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: Clopidogrel Bisulfate
Therapeutic Area: Cardiovascular.
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 | |||
|---|---|---|---|
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| format neat | format neat | format neat | format neat |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical |
| agency USP | agency USP | agency USP | agency USP |
| API family clopidogrel | API family clopidogrel | API family aripiprazole | API family aripiprazole |
signalword
Danger
hcodes
Hazard Classifications
Aquatic Chronic 2 - Eye Dam. 1 - Skin Corr. 1B
Lagerklasse
8A - Combustible corrosive hazardous materials
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
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