1. Characters: White powder; odorless. This product is soluble in ethanol, but insoluble in chloroform; soluble in glacial acetic acid, and soluble in sodium hydroxide test solution.
2. Process: Synthetic.
3. Indications and uses: For the treatment of gallstones, cholestatic liver disease, fatty liver, various types of hepatitis, toxic liver disorders, cholecystitis, cholecystitis and biliary dyspepsia, bile reflux gastritis, etc.
·Produced in the GMP workshop
·27 years of biological enzyme R&D history
·Raw materials are traceable
·Comply with customer and enterprise standard
·Export to over 30 countries and regions
·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.
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Test Items |
According to internal standard and Customer Standard |
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APPEARANCE |
White or almost white powder. |
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MELTING RANGE |
Between 200°C and 205°C |
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SPECIFIC ROTATION |
+57.0 〜+62.0° |
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LOSS ON DRYING |
≤0.5% |
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RESIDUE ON IGNITION |
≤0.1% |
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ASSAY |
98.5%〜101.5% (Dried substance) |
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PURITY (HPLC) |
≥98.5% |
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RELATED SUBSTANCE (HPLC) |
≤1.5% (Chenodeoxycholicacid) |
Not detected |
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≤0.1% (Unspecified impurities) |
0.05% |
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≤0.1% (Lithocholicacid) |
Not detected |
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≤1.5% (Total) |
0.10% |
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RELATED SUBSTANCE (TLC) |
≤O.05% (Lithocholic acid) |
Complies |
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≤1.5% (Chenodeoxycholicacid) |
Complies |
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RESIDUAL SOLVENT |
Acetone： ≤5000ppm |
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TOTAL AEROBIC MICROBIAL COUNT |
＜103cfu/g |
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TOTAL COMBINED YEAST/MOULDS COUNT |
＜102cfu/g |
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E.COLI |
Complies |
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SALMONELLAE |
Complies |
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CONCLUSION |
Qualified |
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