1A00550
USP
(R)-CLOPIDOGREL CARBOXYLIC ACID
Pharmaceutical Analytical Impurity (PAI)
Synonim(y):
(R)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetic acid
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About This Item
Kod UNSPSC:
12352106
NACRES:
NA.24
Polecane produkty
klasa czystości
pharmaceutical analytical impurity (PAI)
agency
USP
rodzina API
clopidogrel
producent / nazwa handlowa
USP
Zastosowanie
pharmaceutical
format
neat
temp. przechowywania
2-8°C
Opis ogólny
(R)-CLOPIDOGREL CARBOXYLIC ACID is a USP Pharmaceutical Analytical Impurity (PAI).
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.
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.
Zastosowanie
(R)-CLOPIDOGREL CARBOXYLIC ACID (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.
Cechy i korzyści
USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:
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.
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.
Komentarz do analizy
These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.
Inne uwagi
Sales restrictions may apply.
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Kod klasy składowania
11 - Combustible Solids
Klasa zagrożenia wodnego (WGK)
WGK 3
Temperatura zapłonu (°F)
Not applicable
Temperatura zapłonu (°C)
Not applicable
Certyfikaty analizy (CoA)
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