1A00800
USP
ATORVASTATIN EPOXY TETRAHYDROFURAN ANALOG
Pharmaceutical Analytical Impurity (PAI)
Synonym(e):
4-(4-Fluorophenyl)-2,4-dihydroxy-2-(1-methylethyl)-N,5-diphenyl-3,6-dioxabicyclo[3.1.0]hexane-1-carboxamide
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Alle Fotos(1)
About This Item
UNSPSC-Code:
41116107
NACRES:
NA.24
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Qualität
pharmaceutical analytical impurity (PAI)
Agentur
USP
API-Familie
atorvastatin
Hersteller/Markenname
USP
Anwendung(en)
pharmaceutical
Format
neat
Lagertemp.
2-8°C
Allgemeine Beschreibung
ATORVASTATIN EPOXY TETRAHYDROFURAN ANALOG 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: Atorvastatin Calcium
Therapeutic Area: Antihyperlipidemics
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: Atorvastatin Calcium
Therapeutic Area: Antihyperlipidemics
For more information about this PAI, visit here.
Anwendung
ATORVASTATIN EPOXY TETRAHYDROFURAN ANALOG (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.
Leistungsmerkmale und Vorteile
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.
Hinweis zur Analyse
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.
Sonstige Hinweise
Sales restrictions may apply.
Lagerklassenschlüssel
11 - Combustible Solids
WGK
WGK 3
Flammpunkt (°F)
Not applicable
Flammpunkt (°C)
Not applicable
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