1A00110

6-Beta-Hydroxy Ethinyl Estradiol

Pharmaceutical Analytical Impurity (PAI)

• 别名: ((6R,8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,6,17-triol)
• 经验公式（希尔记法）: C₂₀H₂₄O₃
• CAS号: 56324-28-8
• 分子量: 312.40
• 分類程式碼代碼: 41116100
• NACRES: NA.24

属性

• 等級: pharmaceutical analytical impurity (PAI)
• agency: USP
• API 家族: ethinyl estradiol
• 製造商／商標名: USP
• 應用: pharmaceutical
• 格式: neat
• 儲存溫度: 2-8°C

说明

一般說明

6-Beta-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.

應用

6-Beta-Hydroxy Ethinyl Estradiol (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

特點和優勢

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.

分析報告

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.

其他說明

Sales restrictions may apply.

安全信息

• 象形圖: GHS08,GHS09
• 訊號詞: Danger
• 危險聲明: H351,H360FD,H362,H410
• 防範說明: P202 - P260 - P263 - P264 - P273 - P308 + P313
• 危險分類: Aquatic Acute 1 - Aquatic Chronic 1 - Carc. 2 - Lact. - Repr. 1A
• 儲存類別代碼: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• 水污染物質分類（WGK）: WGK 3
• 閃點（°F）: Not applicable
• 閃點（°C）: Not applicable