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A propos de cet article
Formule empirique (notation de Hill) :
C25H32O5
Numéro CAS:
Poids moléculaire :
412.52
MDL number:
NACRES:
NA.24
UNSPSC Code:
41116107
Service technique
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pharmaceutical analytical impurity (PAI)
agency
USP
API family
budesonide
manufacturer/tradename
USP
application(s)
pharmaceutical small molecule
format
neat
storage temp.
2-8°C
General description
Find answers to frequently asked questions on USP products in USP FAQs.
Budesonide 9(11)-Ene 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: Budesonide
Therapeutic Area: Steroids
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: Budesonide
Therapeutic Area: Steroids
Application
Budesonide 9(11)-Ene (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.
Features and Benefits
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.
Analysis Note
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.
signalword
Danger
Hazard Classifications
Acute Tox. 4 Oral - Aquatic Chronic 3 - Repr. 2 - Skin Sens. 1 - STOT RE 1 Inhalation
target_organs
Adrenal gland
Classe de stockage
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
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