| Customization: | Available |
|---|---|
| Certification: | ISO, FDA |
| Storage Method: | a Cool, Dry Place, out of Direct Sunlight |
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| Product Name: | Ursodeoxycholic Acid | ||
| Testing Standard: | EP 8.0 Standard | Facility: | GMP Certified |
| Country of Origin: | China | Packing: | 25kgs/Drum |
| ITEMS | SPECIFICATIONS | TEST RESULTS | |
| Description | White or Almost White Crystalline Powder, Taste Bitter and Without Stink | Complies | |
| Identification | Complies with EP Standard | Complies | |
| Related Substance | Lithocholic Acid≤0.1% | Complies | |
| Specific Rotation | +58°~ +62° | +59.4° | |
| Melting Point | 200ºC~204ºC | 202.8ºC~204ºC | |
| Loss on Drying | ≤1.0% | 0.10% | |
| Blazing Residue | ≤0.1% | 0.08% | |
| Assay | 99.0%~101.0% (Tested By HPLC) | 101.0% | |
| Heavy Metals | ≤10ppm | Complies | |
| Purity | CDCA≤1.0% | 0.06% | |
| Each Impurity≤0.1% | 0.085% | ||
| Total Impurities≤1.5% | 0.29% | ||
| Light Transmittance | ≥85.0% | 88.8% | |
| Microbiological Quality According to Current EP 8.0 Standard | |||
| Total Aerobic Microbial Count | ≤1000cfu/g | Complies | |
| Total Combined Yeast/Moulds Count | ≤100cfu/g | Complies | |
| Escherichia Coli | Absence/g | Absence | |
| Salmonellae | Absence/10g | Absence | |
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