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阿奇霉素二水物,117772-70-0,质检单
质量报告单
CERTIFICATE OF ANALYSIS
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Product Name |
Azithromycin dihydrate |
Specification |
200g/Bag |
|
|
Batch No |
240301 |
Batch Quantity |
200kg |
|
|
MFG. Date |
2024.03.03 |
Report Date |
2024.03.05 |
|
|
Exp. Date |
2026.03 |
Testing Basis |
USP XXⅥ |
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|
Test Items |
Specification |
Test Results |
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|
Characters |
A white or almost white crystalline powder |
A white crystalline powder |
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|
Identification |
Positive |
Positive |
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|
Infrared absorption |
Meets the requirement |
Meets the requirement |
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The retention time |
Corresponds to standard preparation |
Meets the requirement |
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|
Test |
||||
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PH |
9.0~11.0 |
9.9 |
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Specific rotation |
-45°～-49° |
-47.0° |
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Crystallinity |
Meets the requirements |
Meets the requirements |
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|
Water |
4.0～5.0% |
4.6% |
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Residue on ignition |
≤0.3% |
0.03% |
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Heavy metals |
≤0.0025% |
＜0.0025% |
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|
Assay |
945 u/mg～1030u/mg |
995u/mg |
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|
Conclusion |
The above product conforms to USP XXⅥ |
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