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CERTIFICATE OF ANALYSIS Reference Substance

Date:

Fulvestrant Sulfone

Batch No.: IUPAC Name: Estra-1,3,5(10)-triene-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfonyl] nonyl]-( 7ι,17β)

OH

O HO

CF2CF3

S O

Molecular Formula: C32H47F5O4S Molecular Weight: 622.77 Sr.# 1 2

Test Appearance Purity by HPLC

Results

Data ref.

Off white solid 91.26%

-----Chromatogram attached

3 4 5 6

MASS 1H NMR TGA Potency

Conform (m/z 645.1(M+Na) Conform For information 91.01%

Report attached Report attached Report attached ------

%Potency =100% - [%organic impurities + %water and volatile matter by TGA] %Potency = 100% - [8.75% +0.24%] =91.01% Storage condition: Store at 0-4 degree temperature and protect from moisture. Shipment date: This certificate of analysis is valid for two years from date of manufacturing, provided the substance is stored under suitable conditions. Manufacturing date: Retest Date:

Document data reference: Prepared by

Reviewed by

Approved by

Fulvestrant sulfone  
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