Customization: | Available |
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Function: | Hormones and Regulation of Endocrine Function of Drug, Roxithromycin |
Certification: | GMP |
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Items | Requirements | Results | |
Appearance | A white or almost white crystalline powder | A white crystalline powder | |
Specific rotation | -82°~-87° | -85.8° | |
Identification (IR) | (1)should be consistent for the trying solution prominent peak retention time with the comparison solution prominent peak retention time | Consistent | |
(2)this infrared light absorption atlas should be consistent with the comparison atlas | Consistent | ||
related substance | The single impurity peak area does not have to be bigger than the comparison solution prominent peak area 1.5 times |
0.9 | |
Each miscellaneous quality area of with can not be big in check against aqua a lord the area of 4.5times | 4.2 | ||
Alkalinity pH |
8.0~10.0 | 9.0 | |
Water | less than 3.0% | 2.8% | |
Residue on ignition | less than 0.1% | 0.06% | |
Heavy metals | less than 10ppm | less than 10ppm | |
on the anhydrous basis | more than 94.0% | 95.9% | |
Conclusion |
The material conform with BP2010 |