Product name

sirolimus

Batch no

20210601

Mfg.date

June 03.2021

Exp.date

June 05.2023

Cas no

53123-88-9

Quantity

200gm

Item

specification

Result

appearance

White or off-white crystalline powder

White crystalline

Identification(IR)

positive

positive

Specific optical rotation

-157^o～+147^o

-150^o

water

≤0.5%

0.2%

Residue on ignition

≤0.2%

0.1%

Heavy metals

≤0.002%

conforms

Impurity A

≤1.0%

0.4%

Impurity B

≤0.5%

0.3%

Impurity D

≤0.5%

Not detected

Individual impurity

≤0.1%

Not detected

Total impurtities(except isomer)

≤0.1%

0.8%

isomer

≤3.5%

2%

Assay

≥98.0%

99.1%

conclusion

Conforms to in-house standard