80621-81-4 Rifaximin 2S-Acetyloxy-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11, 16,20,22,24,26-octamethyl-2,7-(epoxypentoeleca(1,11,13)trienimino)benzofuro[4,5-e]pyride[1,2-a]benzimidazole-1,15(2H)-dione
Item |
Specifications |
Results |
Characters |
A res-orange hygroscopic crystalline powder |
|
Solubility |
Conforms |
Conforms |
Identification |
IR |
Conforms |
Related substances |
||
Sum of impurities D and H(D+H) |
≤0.5% |
0.32% |
Unspecified impurities |
≤0.4% |
0.30% |
Total impurities |
≤1.0% |
0.90% |
Heavy metals |
≤20ppm |
Conforms |
Water |
≤4.5% |
3.8% |
Sulfated ash |
≤0.1% |
Conforms |
Assay |
97.0%~102.0% |
99.0% |
Conclusion |
The results conforms with Enterprise standards |
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