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CERTIFICATE OF ANALYSIS
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 |
|
Test Items |
Specification |
Test Results |
||
Characters |
A white or almost white crystalline powder |
A white crystalline powder |
||
Identification |
Positive |
Positive |
||
Infrared absorption |
Meets the requirement |
Meets the requirement |
||
The retention time |
Corresponds to standard preparation |
Meets the requirement |
||
Test |
||||
PH |
9.0~11.0 |
9.9 |
||
Specific rotation |
-45°~-49° |
-47.0° |
||
Crystallinity |
Meets the requirements |
Meets the requirements |
||
Water |
4.0~5.0% |
4.6% |
||
Residue on ignition |
≤0.3% |
0.03% |
||
Heavy metals |
≤0.0025% |
<0.0025% |
||
Assay |
945 u/mg~1030u/mg |
995u/mg |
||
Conclusion |
The above product conforms to USP XXⅥ |