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文件

安全信息

1A02020

USP

9-Bromo-16Alpha-Hydroxyprednisolone

Pharmaceutical Analytical Impurity (PAI)

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别名:
((8S,9R,10S,11S,13S,14S,16R,17S)-9-bromo-11,16,17-trihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one)
经验公式(希尔记法):
C21H27BrO6
分子量:
455.34
UNSPSC代码:
41116100
NACRES:
NA.24

等级

pharmaceutical analytical impurity (PAI)

Agency

USP

制造商/商品名称

USP

应用

pharmaceutical

格式

neat

储存温度

2-8°C

一般描述

9-Bromo-16Alpha-Hydroxyprednisolone 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.

For more information about this PAI, visit here.

应用

9-Bromo-16Alpha-Hydroxyprednisolone (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

特点和优势

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.

分析说明

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.

其他说明

Sales restrictions may apply.

象形图

Health hazard

警示用语:

Danger

危险声明

危险分类

Repr. 1B

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

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