1A00100

6-Alpha-Hydroxy Ethinyl Estradiol

Pharmaceutical Analytical Impurity (PAI)

• Sinónimos: (19-Nor-17alpha-pregna-1,3,5(10)-trien-20-yne-3,6alpha,17-triol)
• Fórmula empírica (notación de Hill): C₂₀H₂₄O₃
• Número de CAS: 27521-34-2
• Peso molecular: 312.40
• Código UNSPSC: 41116100
• NACRES: NA.24

Propiedades

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

Descripción

Descripción general

6-Alpha-Hydroxy Ethinyl Estradiol 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: Ethinyl Estradiol

Therapeutic Area: Steroids.

For more information about this PAI, visit here.

Aplicación

6-Alpha-Hydroxy Ethinyl Estradiol (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,GHS09
• Palabra de señalización: Danger
• Frases de peligro: H351,H360FD,H362,H410
• Consejos de prudencia: P202 - P260 - P263 - P264 - P273 - P308 + P313
• Clasificaciones de peligro: Aquatic Acute 1 - Aquatic Chronic 1 - Carc. 2 - Lact. - Repr. 1A
• Código de clase de almacenamiento: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Clase de riesgo para el agua (WGK): WGK 3
• Punto de inflamabilidad (°F): Not applicable
• Punto de inflamabilidad (°C): Not applicable