Tacrolimus monohydrate

【Product Name】:Tacrolimus monohydrate

【CAS NO.】: 109581-93-3

【Molecular Weight】: 822.03

【Formula】:C44H69NO12·H2O

【Quality Standards】:EP, USP

【Package】:1g /10g/100g per bag


Tacrolimus monohydrate

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【Appearance】

White crystals or white crystalline powder

【Identification】

IR,HPLC 

【Optical rotation】

-110° to -115°

【Residue on ignition】

≤ 0.1%

【Heavy metals】

≤10ppm

【Related substances (HPLC)】

Ascomycin-19-epimer≤ 0.1% ; 

Ascomycin≤0.5%; 

Desmethyl tacrolimus≤ 0.1%; 

Tacrolimus8-epimer≤0.15%; 

Tacrolimus 8-propyl analog≤0.15%;

【Any individual impurity】

≤0.1%

【Total impurities】

≤1.0%

【Residual solvent】

Ethanol≤0.5%; 

Acetone≤0.5%; 

Ethyl acetate≤0.5%; 

Isopropyl ether≤0.05%

【Assay】

98.0% ~102.0%

【Usage】

Immune system

【Storage】

Preserve in tight containers. Store at controlled room temperature.








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