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21873. Chester 18-12-2019, 17:49:11
email  homepage In one embodiment, the amount of Compound 1 in the lyophilized formulation is about 0.36% based on the  
total weight of the lyophilized formulation. In one embodiment, 
the amount of anhydrous sodium citrate is about 17.6 mg in a 20 cc vial. 
 
In still another aspect is a lyophilized formulation that comprises anhydrous sodium citrate in an amount  
of about 5 mg to about 20 mg in a 20 cc vial. In still another embodiment, Form D of Compound 1 is substantially pure. 
In certain embodiments, the lyophilized formulations provided  
herein are prepared from Form D of Compound 1. In certain embodiments, Form  
D of Compound 1 is a DMSO solvate. In certain embodiments, the lyophilized formulations provided herein are prepared from Form  
E of Compound 1. In certain embodiments, Form E of Compound 1 is a DMSO solvate. 
In one embodiment, the amount of Compound 1 in the  
lyophilized formulation is about 0.9 to about 1% based on the total weight of the lyophilized formulation. In one embodiment, 
the lyophilized formulations of Compound 1 comprise an amorphous form of 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)m- ethyl)-2,2-difluoroacetamide. 
Provided herein are stable lyophilized formulations of Compound 1. 
In one embodiment, the lyophilized formulations of Compound 1 comprise a solid form of 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindoli- n-5-yl)methyl)-2,2-difluoroacetamide.
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