1A00800
USP
ATORVASTATIN EPOXY TETRAHYDROFURAN ANALOG
Pharmaceutical Analytical Impurity (PAI)
Sinonimo/i:
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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About This Item
Codice UNSPSC:
41116107
NACRES:
NA.24
Prodotti consigliati
Grado
pharmaceutical analytical impurity (PAI)
agenzia
USP
Famiglia di API
atorvastatin
Produttore/marchio commerciale
USP
applicazioni
pharmaceutical
Formato
neat
Temperatura di conservazione
2-8°C
Descrizione generale
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.
Applicazioni
ATORVASTATIN EPOXY TETRAHYDROFURAN ANALOG (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.
Caratteristiche e vantaggi
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.
Risultati analitici
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.
Altre note
Sales restrictions may apply.
Codice della classe di stoccaggio
11 - Combustible Solids
Classe di pericolosità dell'acqua (WGK)
WGK 3
Punto d’infiammabilità (°F)
Not applicable
Punto d’infiammabilità (°C)
Not applicable
Certificati d'analisi (COA)
Cerca il Certificati d'analisi (COA) digitando il numero di lotto/batch corrispondente. I numeri di lotto o di batch sono stampati sull'etichetta dei prodotti dopo la parola ‘Lotto’ o ‘Batch’.
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