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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
manufacturer/tradename
USP
application(s)
pharmaceutical
format
neat
storage temp.
2-8°C
SMILES string
Oc1c2c(ccc1)cccc2
InChI key
KJCVRFUGPWSIIH-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: Duloxetine
Therapeutic Area: Psychiatrics.
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 | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description puriss. p.a., reag. Ph. Eur., ≥99% (GC) | description BioXtra, ≥99% | description ReagentPlus®, ≥99% |
| grade pharmaceutical analytical impurity (PAI) | grade puriss. p.a. | grade - | grade - |
| manufacturer/tradename USP | manufacturer/tradename - | manufacturer/tradename - | manufacturer/tradename - |
| format neat | format - | format - | format - |
| application(s) pharmaceutical | application(s) - | application(s) diagnostic assay manufacturing | application(s) cleaning products |
| storage temp. 2-8°C | storage temp. - | storage temp. room temp | storage temp. - |
| agency USP | agency reag. Ph. Eur., USP/NF | agency - | agency - |
Signalwort
Danger
Gefahrencodes
Hazard Classifications
Acute Tox. 3 Dermal - Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 3 - Eye Dam. 1 - Skin Irrit. 2 - Skin Sens. 1A - STOT SE 2 Oral - STOT SE 3
Zielorgane
Kidney, Respiratory system
Lagerklasse
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
Was ist los?
WGK 1
Flammpunkt (°F)
Not applicable
Flammpunkt (°C)
Not applicable
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