Detection Technique for Determination of Residual Solvents in the API Tacrolimus

Weiwei Wu; Yadan Mao; Zhong Chen; Dandan Wang

doi:10.6911/WSRJ.202408_10(8).0003

Authors

Weiwei Wu
Yadan Mao
Zhong Chen
Dandan Wang

DOI:

https://doi.org/10.6911/WSRJ.202408_10(8).0003

Keywords:

Tacrolimus, Ethanol, Ethyl acetate, Butyl acetate, N-hexane, Cyclohexane, Toluene, Acetonitrile, Acetone, Residue, Organic solvent.

Abstract

To establish the detection technique for determination of the residual solvents ethanol, ethyl acetate, butyl acetate, N-hexane or cyclohexane, toluene, acetonitrile and acetone popularly used as the solvents for preparation of the active pharmaceutical ingredient (API) tacrolimus as reported, in order to control the quality of the API, to be in line with the requirement as stated in ICH Q3C.

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