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Product Name: |
Everolimus |
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Batch No.: |
20240110 |
Mfg. Date: |
2024-01-10 |
Analysis Date: |
2024-01-10 |
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Quantity: |
65G |
CAS: |
159351-69-6 |
Exp. Date: |
2026-01-09 |
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Storage: |
Packing in tight containers, protected from light at temperature lower than 0℃. |
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ITEM AND RESULT |
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Appearance |
White to off-white powder |
White powder |
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Solubility |
Freely soluble in methanol or ethanol practically insoluble in water. |
Conform |
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Identification |
IR: Spectrum of the sample corresponds to that of reference standard |
Conform |
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HPLC: The retention time of the major peak of test solution should correspond to that of comparison solution. |
Conform |
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Specific optical rotation |
-143°~-153° |
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Related substances |
EMB≤0.15% |
ND |
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Individual unknown impurity≤0.10% |
0.04% |
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Total unknown impurities≤1.0% (Excluding Tautomer, 7-Ring isomer and BHT) |
0.07% |
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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% |
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Sirolimus |
≤0.15% |
0.005% |
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BHT |
1.7%~2.3% |
2.0% |
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Residual solvents I |
Isopropanol ≤1000ppm |
ND |
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Dichloromethane ≤600ppm |
ND |
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n-Heptane ≤1000ppm |
2ppm |
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Ethyl acetate ≤1000ppm |
21ppm |
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Toluene ≤890ppm |
ND |
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1,2-Dimethoxyethane ≤100ppm |
ND |
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Methanol ≤3000ppm |
ND |
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Ethanol ≤5000ppm |
35ppm |
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Triethylamine ≤320ppm |
ND |
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Methyl formate ≤100ppm |
23ppm |
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Residual solvents II |
Ethylene glycol ≤620ppm |
ND |
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Water |
≤2.0% |
0.8% |
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Residue on ignition |
≤0.1% |
0.04% |
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Heavy metal |
≤20ppm |
Conform |
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Assay |
98.0%~102.0% (on anhydrous and solvents free basis) |
100.8% |
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Conclusion: |
Complies with Enterprise Standard. |
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-144°
