1A01220

16ALPHA-HYDROXY PREDNISOLONE-14-ENE ACETATE

Pharmaceutical Analytical Impurity (PAI)

• Sinónimos: 2-Oxo-2-((8R,9S,10R,11S,13S,16R,17S)-11,16,17-trihydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,1 2,13,16,17-decahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate
• Código UNSPSC: 41116107
• NACRES: NA.24

Propiedades

• grado: pharmaceutical analytical impurity (PAI)
• Agency: USP
• familia API: prednisolone
• fabricante / nombre comercial: USP
• aplicaciones: pharmaceutical
• formato: neat
• temp. de almacenamiento: 2-8°C

Descripción

Descripción general

16ALPHA-HYDROXY PREDNISOLONE-14-ENE ACETATE 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.

Aplicación

16ALPHA-HYDROXY PREDNISOLONE-14-ENE ACETATE (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Características y beneficios

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.

Nota de análisis

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.  

Otras notas

Sales restrictions may apply.

Información de seguridad

• Pictogramas: GHS08
• Palabra de señalización: Warning
• Frases de peligro: H361
• Consejos de prudencia: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Clasificaciones de peligro: Repr. 2
• Código de clase de almacenamiento: 11 - Combustible Solids
• Clase de riesgo para el agua (WGK): WGK 3
• Punto de inflamabilidad (°F): Not applicable
• Punto de inflamabilidad (°C): Not applicable