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　Products：Tacrolimus他克莫司
　Specification
Tacrolimus他克莫司
 
Product name
Tacrolimus
 
Date of analysis
 
Batch No.
 
100917
 
Batch size
                                      
Test
Specification
Characters
 
Appearance:
White crystal powder
 
HPLC
 
Preparation corresponds to that of the
chromatogram of the standard preparation
Obtained as directed in the Assay
 
Related substances
Each: ≤0.5%
Sum: ≤1.0%
Specific rotation
 
 
Between -75.0° ~ -90°
Residual of solvents
Hexane        ≤ 290ppm
Acetone        ≤ 5000ppm
Ethanol        ≤ 5000ppm
Heavy metals
 
≤0.001%
Water
 
≤3.0%
Residue on Ignition
≤0.1%
Assay
≥98.5%
 
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