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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
ticlopidine
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°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: Clopidogrel Bisulfate
Therapeutic Area: Cardiovascular
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
1 of 1
Dieser Artikel | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland | description Pharmaceutical Analytical Impurity (PAI) | description certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland |
| manufacturer/tradename USP | manufacturer/tradename Manufactured by: Sigma-Aldrich Production GmbH, Switzerland | manufacturer/tradename USP | manufacturer/tradename Manufactured by: Sigma-Aldrich Production GmbH, Switzerland |
| grade pharmaceutical analytical impurity (PAI) | grade certified reference material, TraceCERT® | grade pharmaceutical analytical impurity (PAI) | grade certified reference material, TraceCERT® |
| application(s) pharmaceutical small molecule | application(s) pharmaceutical | application(s) pharmaceutical small molecule | application(s) pharmaceutical |
| format neat | format - | format neat | format - |
| API family ticlopidine | API family ticlopidine | API family ticlopidine | API family ticlopidine, clopidogrel |
| agency USP | agency (Not traceable to any primary pharmacopeia standard) | agency USP | agency Not traceable to any primary pharmacopeia standard |
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Lagerklasse
11 - Combustible Solids
Was ist los?
WGK 3
Flammpunkt (°F)
Not applicable
Flammpunkt (°C)
Not applicable
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