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Informazioni su questo articolo
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
desloratadine
manufacturer/tradename
USP
application(s)
pharmaceutical
format
neat
storage temp.
2-8°C
SMILES string
Clc1cc2c(cc1)C(=C4CCNCC4)c3ncc(cc3CC2)O
InChI
1S/C19H19ClN2O/c20-15-3-4-17-13(9-15)1-2-14-10-16(23)11-22-19(14)18(17)12-5-7-21-8-6-12/h3-4,9-11,21,23H,1-2,5-8H2
InChI key
NDFMTPISBHBIKE-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: Desloratadine
Therapeutic Area: Antihistamines.
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
Questo articolo | |||
|---|---|---|---|
| grade pharmaceutical analytical impurity (PAI) | grade - | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) |
| manufacturer/tradename USP | manufacturer/tradename - | manufacturer/tradename USP | manufacturer/tradename USP |
| format neat | format - | format neat | format neat |
| application(s) pharmaceutical | application(s) - | application(s) pharmaceutical | application(s) pharmaceutical |
| API family desloratadine | API family - | API family ivabradine | API family - |
| storage temp. 2-8°C | storage temp. −20°C | storage temp. 2-8°C | storage temp. 2-8°C |
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Classe di stoccaggio
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
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