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Rifaximin

80621-81-4

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Description

Specifications

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Specifications
Product:Rifaximin/ Xifaxan EP/USP/BP
Formulate:C43H51N3O11
Formula weight:785.88
CAS: 80621-81-4

Appearance :Orange-red or dark red powder;odourless and slightly bitter

Items
Standard
Results

Description
Reddish Orange Powder
Conforms
Identification
Positive
Positive
Acidity(PH value)
5.5-7.0
6.1
Related Materials
Single Impurity ≤0.1%
0.1%
Impurity D+H <0.5%
0.4%
Total Impurity<1.0%
0.8%
Loss on drying
≤4.5%
2.6%
Solubility
Practically insoluble in water, soluble in acetone and in methanol
Conforms
Residual solvents
<5000ppm
<5000ppm
Residue on ignition
≤0.1%
0.10%
Mesh size
Pass 120 mesh
Conforms
Heavy metals
≤20ppm
Conforms
Assay
>97.0%-102%
99.0%
Conclusion
It conforms to EP5.0

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