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Roxithromycin
| ITEMS | LIMIT |
| Appearance | A white or almost white crystalline powder |
| Specific rotation | -82°~-87 |
| Identification (IR) | (1)should be consistent for the trying solution prominent peak retention time with the comparison solution prominent peak retention time |
| (2)this infrared light absorption atlas should be consistent with the comparison atlas | |
| related substance | The single impurity peak area does not have to be bigger than the comparison solution prominent peak area 1.5 times |
| Each miscellaneous quality area of with can not be big in check against aqua a lord the area of 4.5times | |
| Alkalinity pH | 8.0~10.0 |
| Water | less than 3.0% |
| Residue on ignition | less than 0.1% |
| Heavy metals | less than 10ppm |
| On the anhydrous basis | more than 94.0% |
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