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PRODUCT NAME: |
TESTOSTRONE UNDECANOATE |
BATCH NO |
1809001 |
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MFG DATE |
2018/09/02 |
EXP DATE |
2021/09/01 |
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TEST ITEMS |
SPECIFICATION |
RESULTS |
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Description |
White or Almost White Crystalline Powder |
White Powder |
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Solubility |
Free soluble in Chloroform,soluble in Ethanol,sparingly soluble in Methanol and Vegitable oil.insoluble in water. |
Conforms |
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Identification |
1)Sulforic acid & Ethanol Solution |
Positive |
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2)HPLC with RS |
Positive |
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3)IR |
Positive |
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Assay |
97.0~103.0% |
99.56% |
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Specific Rotation |
+68~+72℃ |
+69.9° |
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Loss On Drying |
0.5%max |
0.22% |
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Melting Point |
60~63℃ |
60.5~62.5°C |
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Related Substances |
Individual Impurity:0.5%max |
0.20% |
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Total Impurities:2.0%max |
0.70% |
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Testosterone:0.5%max |
0.20% |
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Testosterone Decanoate:0.5%max |
Undectable |
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Residual Solvents |
Ethanol:5000ppm max |
<500ppm |
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Acetone:5000ppm max |
Undectable |
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N-Hexane:290ppm max |
Undectable |
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Isopropyl Ether:1500ppm max |
Undectable |
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Toluene:890ppm max |
<200ppm |
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Pyridine:200ppm max |
<100ppm |
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Methanol:3000ppm max |
<500ppm |
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Conclusion |
The specification conform with enterprise standard |
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