Commodity: Ketoconazole Cas No.: 65277-42-1
MFG Date：2024.04.15Batch No：FH20240415
EXP Date ：2028.04.15Quantity：500kg
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Specification |
Results |
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Characters |
Almost white power |
Almost white power |
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Identification |
Positive |
Positive |
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Appearance of solution |
Solution S should be clear and not more intensely |
Complies |
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Solubility |
Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in alcohol. |
Complies |
|
Specific optical rotation |
Between-0.10° and +0.10° |
0.001° |
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Related substances |
≤0.5% |
0.16 % |
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Heavy metals |
≤20ppm |
＜ 20ppm |
|
Loss on drying |
≤0.5% |
0.06% |
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Sulphated ash |
≤0.1% |
0.04% |
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Assay |
99.0% ～ 101.0% |
99.9% |
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Total Aerobic Microbial Count |
≤102cfu/g |
Qualified |
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Total Yeasts and Molds Count |
≤10'cfu/g |
Qualified |
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Pseudomonas aeruginosa |
Absent per g |
Qualified |
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Staphylococcus aureus |
Absent per g |
Qualified |
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Conclusion |
The quality of the above commodity complies standard of BP/EP |
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Packaging and storage |
Preserve in well-closed containers, protected from light for 48 months. |
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