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Tacrolimus coa
1. OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-13071891945 FAX:0086-0535-6715688
Address: ROOM 5032,NO.9 YANAN ROAD,HANGZHOU,CHINA
sales@octagonchem.com
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Product name Tacrolimus (Cas 104987-11-3)
Batch No. 19120503 Mfg. date 2019.12.13
Rep. Date 2019.12.18 Exp. date 2021.12.12
Packaging 1kg/Tin Batch Size 1000.9g
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) 100.03%
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