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Key Documents

1A02010

USP

17ALPHA-HYDROXY13(17)A-HOMOPREDNISOLONE

Pharmaceutical Analytical Impurity (PAI)

Synonyme(s) :

2R,3R,4aS,4bS,10aR,10bS,11S,12aS)-2,3,11-trihydroxy-2-(hydroxymethyl)-10a,12a-dimethyl-3,4, 4a,5,6,10a,10b,11,12,12a-decahydrochrysene-1,8(2H,4bH)-dione

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About This Item

Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

pharmaceutical analytical impurity (PAI)

Agence

USP

Famille d'API

prednisolone

Fabricant/nom de marque

USP

Application(s)

pharmaceutical

Format

neat

Température de stockage

2-8°C

Description générale

17ALPHA-HYDROXY13(17)A-HOMOPREDNISOLONE 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

For more information about this PAI, visit here.

Application

17ALPHA-HYDROXY13(17)A-HOMOPREDNISOLONE (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Caractéristiques et avantages

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.

Remarque sur l'analyse

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.  

Autres remarques

Sales restrictions may apply.

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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