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1A01220

USP

16ALPHA-HYDROXY PREDNISOLONE-14-ENE ACETATE

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

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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25 MG
R 24 801,84

R 24 801,84

List PriceR 25 308,00
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25 MG
R 24 801,84

About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

R 24 801,84

List PriceR 25 308,00
Please contact Customer Service for Availability
Request a Bulk Order

grade

pharmaceutical analytical impurity (PAI)

Agency

USP

API family

prednisolone

manufacturer/tradename

USP

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

General description

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.

Application

16ALPHA-HYDROXY PREDNISOLONE-14-ENE ACETATE (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.

Pictograms

Health hazard
GHS08

Signal Word

Warning

Hazard Statements

H361

Hazard Classifications

Repr. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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