1A00100

6-Alpha-Hydroxy Ethinyl Estradiol

Pharmaceutical Analytical Impurity (PAI)

• Sinonimo/i: (19-Nor-17alpha-pregna-1,3,5(10)-trien-20-yne-3,6alpha,17-triol)
• Formula empirica (notazione di Hill): C₂₀H₂₄O₃
• Numero CAS: 27521-34-2
• Peso molecolare: 312.40
• MDL number: MFCD01310740
• NACRES: NA.24
• UNSPSC Code: 41116107
• eCl@ss: 25140904

Proprietà

• grade: pharmaceutical analytical impurity (PAI)
• agency: USP
• API family: ethinyl estradiol
• manufacturer/tradename: USP
• application(s): pharmaceutical
• format: neat
• storage temp.: 2-8°C

Descrizione

General description

Find answers to frequently asked questions on USP products in USP FAQs.

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.

Application

6-Alpha-Hydroxy Ethinyl Estradiol (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.

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.

Other Notes

Sales restrictions may apply.

Informazioni sulla sicurezza

• Pittogrammi: GHS08,GHS09
• Parola di avvertenza: Danger
• Codici di pericolo: H351,H360FD,H362,H410
• Avvertenze di sicurezza: P202 - P260 - P263 - P264 - P273 - P308 + P313
• Hazard Classifications: Aquatic Acute 1 - Aquatic Chronic 1 - Carc. 2 - Lact. - Repr. 1A
• Classe di stoccaggio: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Che succede?: WGK 3
• Punto di infiammabilità (°F): Not applicable
• Punto di infiammabilità (°C): Not applicable