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| Talla/SKU | Disponibilidad | Precio |
|---|
Acerca de este artículo
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
azithromycin
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
2-8°C
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: Azithromycin
Therapeutic Area: Antibiotics
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
1 of 1
Este artículo | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description European Pharmacopoeia (EP) Reference Standard | description United States Pharmacopeia (USP) Reference Standard | description United States Pharmacopeia (USP) Reference Standard |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical primary standard | grade pharmaceutical primary standard | grade pharmaceutical primary standard |
| manufacturer/tradename USP | manufacturer/tradename EDQM | manufacturer/tradename USP | manufacturer/tradename USP |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical |
| format neat | format neat | format neat | format neat |
| agency USP | agency - | agency USP | agency USP |
| API family azithromycin | API family azithromycin | API family azithromycin | API family azithromycin |
Palabra de advertencia
Danger
Códigos de peligro
Indicaciones de precaución
Hazard Classifications
Aquatic Chronic 1 - Resp. Sens. 1 - Skin Sens. 1
Clase de almacenamiento
11 - Combustible Solids
¿Qué está pasando?
WGK 2
Punto de inflamación (°F)
Not applicable
Punto de inflamación (°C)
Not applicable
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