1A01220
USP
16ALPHA-HYDROXY PREDNISOLONE-14-ENE ACETATE
Pharmaceutical Analytical Impurity (PAI)
别名:
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
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About This Item
分類程式碼代碼:
41116107
NACRES:
NA.24
推荐产品
等級
pharmaceutical analytical impurity (PAI)
agency
USP
API 家族
prednisolone
製造商／商標名
USP
應用
pharmaceutical
格式
neat
儲存溫度
2-8°C
一般說明
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.
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.
應用
16ALPHA-HYDROXY PREDNISOLONE-14-ENE ACETATE (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.
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.
訊號詞
Warning
危險聲明
危險分類
Repr. 2
儲存類別代碼
11 - Combustible Solids
水污染物質分類（WGK）
WGK 3
閃點（°F）
Not applicable
閃點（°C）
Not applicable
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