Roxithromycin high purity 94.7%
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Appearance |
A white or almost white crystalline powder |
A white crystalline powder |
Specific rotation |
-82°~-87° |
-85.4° |
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 |
4.3 |
|
Alkalinity |
8.0~10.0 |
9.0 |
Water |
≤3.0% |
2.7% |
Residue on ignition |
≤0.1% |
0.06% |
Heavy metals |
≤10ppm |
<10ppm |
(on the anhydrous basis) |
≥94.0% |
94.7% |
Conclusion |
The material conform with"Chinese Pharmacopoeia" in 2005 version two。 |
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