NORTH CHINA PHARMACEUTICAL HUASHENG CO., LTD.

CERTIFICATE OF ANALYSIS
Add: No. 8 Yangzi Road, Shijiazhuang Economic & Technological Development Zone, Hebei 052160, China
Tel:+86-311-83090290 Fax:+86-311-83090280 Website: http://www.ncpchs.com E-mail:mail@ncpchs.com
Product name ：Tacrolimus
Tacrolimus
Batch No. ： HNTN2301502U Manuf. date ： 2023.01.19
Cert. No. ： P-NT-01 Report date ： 2023.02.10
Batch size ： 11.478kg Retest date ： 2026.01.18

Tests Specifications Results

Characters White crystals or white crystalline powder White crystalline powder
Identification A Infrared absorption Complies
B The retention time of the major peak of
the Sample solution corresponds to that of
the Standard solution as obtained in the Complies
Assay
Residue on ignition NMT 0.1% 0.05%
Optical rotation -110°to -115° -111°
Water NMT 4.0% 2.1%
Organic impurities
Ascomycin 19-epimer NMT 0.1% Not detected
Ascomycin NMT 0.50% Not detected
Desmethyl tacrolimus NMT 0.1% Not detected
Tacrolimus 8-epimer NMT 0.15% Not detected
Tacrolimus 8-propyl analog NMT 0.15% Not detected
Any individual unspecified NMT 0.1%
impurity Not detected
Total impurities NMT 1.0% Not detected
Assay(on the anhydrous and 98.0～102.0%
solvent-free basis) 100.1%
Residual solvent
Ethanol NMT 0.5% Not detected
Acetone NMT 0.5% Not detected
Ethyl acetate NMT 0.5% 0.003%
Isopropyl ether NMT 0.05% Not detected
Co n cl u si o n ： Co mp l i es wit h cu r r en t USP
Reporter： Manager of QC division： Qualified Person：