Items of Analysis

Specification

Results

Appearance

White powder

Conform

Identification

H-NMR/HPLC

Conform

Loss On Dry

≤0.50%

0.20%

Heavy Metals

≤ 0.002%

<0.002%

Individual Impurity

≤ 1.0%

0.38%

Total Impurities

≤2.0%

0.79%

Cis-Stereoisomer of Sirolimus

≤ 5.0%

0.60%

Assay(HPLC)

≥98%

Conform

Ethanol

≤5000PPM

Not Detected

Ethyl Acetate

≤5000PPM

70PPM

Petroleum Ether

≤1000PPM

Not Detected

Acetone

≤5000PPM

Not Detected

Remark

Declaration: For laboratory use only - not for drug, household or other use.

Conclusion

Conform with specification