Product Name:

Everolimus

Batch No.:

20240110

Mfg. Date:

2024-01-10

Analysis Date:

2024-01-10

Quantity:

65G

CAS:

159351-69-6

Exp. Date:

2026-01-09

Storage:

Packing in tight containers, protected from light at temperature lower than 0℃.

ITEM AND RESULT

Appearance

White to off-white powder

White powder

Solubility

Freely soluble in methanol or ethanol practically insoluble in water.

Conform

Identification

IR: Spectrum of the sample corresponds to that of reference standard

Conform

HPLC: The retention time of the major peak of test solution should

correspond to that of comparison solution.

Conform

Specific optical rotation

-143°~-153°

-144°

Related substances

EMB≤0.15%

ND

Individual unknown impurity≤0.10%

0.04%

Total unknown impurities≤1.0% (Excluding Tautomer, 7-Ring isomer

and BHT)

0.07%

Tautomer and 7-Ring

isomer

Tautomer(RRT0.80) peak area≤0.5% of the sum of the tautomer, 7-ring

isomer, and main peak area.

0.20%

Sirolimus

≤0.15%

0.005%

BHT

1.7%~2.3%

2.0%

Residual solvents I

Isopropanol ≤1000ppm

ND

Dichloromethane ≤600ppm

ND

n-Heptane ≤1000ppm

2ppm

Ethyl acetate ≤1000ppm

21ppm

Toluene ≤890ppm

ND

1,2-Dimethoxyethane ≤100ppm

ND

Methanol ≤3000ppm

ND

Ethanol ≤5000ppm

35ppm

Triethylamine ≤320ppm

ND

Methyl formate ≤100ppm

23ppm

Residual solvents II

Ethylene glycol ≤620ppm

ND

Water

≤2.0%

0.8%

Residue on ignition

≤0.1%

0.04%

Heavy metal

≤20ppm

Conform

Assay

98.0%~102.0% (on anhydrous and solvents free basis)

100.8%

Conclusion:

Complies with Enterprise Standard.