This certificate of analysis from Octagon Chemicals Limited provides the results of quality testing on a batch of 1,000 grams of tacrolimus. All tests, including for appearance, identification, optical rotation, heavy metals, related substances, residual solvents, and assay, met the standards of the United States Pharmacopeia 40th edition. The batch is approved for storage in a well-closed container at ambient temperature until its expiration date of December 12, 2021.

1. OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-13071891945 FAX:0086-0535-6715688
Address: ROOM 5032,NO.9 YANAN ROAD,HANGZHOU,CHINA
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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