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Tacrolimus coa
1. SHANDONG OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-15589503653 FAX:0086-0535-6715688
Address: Rm 528, Building 2, No. 300-2, Changjiang Rd, YEDA, YanTai City, ShanDong
Province, China sales@octagonchem.com
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Product name Tacrolimus (Cas 104987-11-3)
Batch No. 20100503 Mfg. date 2020.10.19
Rep. Date 2020.10.28 Exp. date 2022.10.18
Packaging 1kg/Tin Batch Size 1000.4g
Test Items Standards: USP40 Results
Appearance
Odorless white to off-white crystalline
powder
conforms
Identification
IR Conforms
HPLC Conforms
Optical rotation -110 ~ -115° -112°
Heavy metals NMT10ppm <10ppm
Related Substances Should conform Conforms
Residual solvents Should conform Conforms
Assay 98.0%~102.0% (on dried basis) 100.01%
Conclusion It meets the requirements of USP40 Standards
Storage Store in a well-closed container at ambient temperature
Prepared by: LI Reviewed by: WEI Released by:Zhang