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1 Kilogram |
FOB Price: USD 3.0000 |
Product Name: Dirithromycin CAS No.: 62013-04-1 Place of Origin: Jiangxi China (Mainland)
Items |
Acceptance Criteria |
Results |
|
Character |
Appearance: White to almost white powder |
A white powder |
|
Identification |
Infrared absorption Spectrophotometry :the IR spectrum is consistent with that obtained with dirithromycin CRS |
|
|
The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay |
|
||
Test |
Chromatographic Purity |
9-(S)-erythromycylamine ; no more than 1.5% |
0.2precent |
Any other individual impurity : not more than 1.0% |
Less than 1.0percent |
||
Total impurities : not more than 4.0 percent |
2.2 percent |
||
Dirithromycin 16S-epimer |
Not more than 1.5percent |
0.7precent |
|
Acetonitrile |
Not more than 0.1 percent |
Less than 0.1 percent |
|
Heavy metals |
Not more than 20ppm |
Less than 20ppm |
|
Water |
Not more than 1.0 percent |
0.5 percent |
|
Assay |
Dirithromycin contains not less than 96.0% percent and not more than 102.0 percent consisting of the 16R-and 16S-epimers .calculated on the anhydrous basis |
97.6 percent |
|
Conclusion |
This batch of Dirithromycin meets the specification of USP31 |
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