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Tests |
Specifications |
Results |
|
Identification |
Corresponds |
Corresponds |
|
Crystallinity |
Meets the requirements |
Meets the requirements |
|
PH |
9.0~11.0 |
10.02 |
|
Specific optical rotation |
-45.0°~ -49.0° |
-46.0° |
|
Limit of related substances |
Azithromycin-N-Oxide |
≤0.4% |
Undetected |
3'-(N,N-didemethyl)-3'-N-formylazithromycin |
≤0.3% |
0.01% |
|
3'-(N,N-didemethyl)-3'-N-formylazithromycin(Rotamer1) |
≤0.15% |
0.03% |
|
3'-(N,N-didemethyl)-3'-N-formylazithromycin(Rotamer2) |
≤0.15% |
0.05% |
|
Azaerythromycin A |
≤0.50% |
0.09% |
|
3'-De)dimethylamono)-3'-oxoazithromycin |
≤0.25% |
0.03% |
|
2-Desethyl-2-Propylazithromycin |
≤0.50% |
0.17% |
|
Azithromycin B |
≤0.50% |
0.23% |
|
3'-N-demethyl-3'-N-[(4-metylphenyl)sulfonyl] azithromycin |
≤0.50% |
Undetected |
|
Individual unknown impurity |
≤0.20% |
0.08% |
|
Total impurities |
≤2.0% |
0.92% |
|
Heavy metals |
≤25ppm |
<25ppm |
|
Water |
4.0~5.0% |
4.51% |
|
Residue on ignition |
≤0.3% |
0.03% |
|
Assay |
945~1030 ug/mg |
980 ug/mg |
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