Pharma Grade
USP/Ep/Bp/Jp/IP
Treatment of Gallstone Disease
China
25kg/Drum
99.0%
Sinochem
29372900
Product Description
CERTIFICATE OF ANALYSIS
Microbiological Tests
| Product | Ursodeoxycholic Acid (UDCA) | Batch No. | 201705002 |
| Expiry Date | 2017.APR.26 | Retest Date | 2020.APR.25 |
| Quantity | 100KG | CAS NO. | 128-13-2 |
| Item | Specification | Results |
| Appearance | White or almost white powder | Complies |
| Solubility | Practically insoluble in water, freely soluble in ethnol (96%), slightly soluble in acetone, Practically insoluble in methylene chloride. | Complies |
| Identification | Infrared Absorption, TLC and chrominance test | Complies |
| Melting Point | 200-204ºC | 202.5ºC |
| Specific Optical Rotation | +58.0°~ +62.0° | +60.2° |
| Heavy metals | ≤20 ppm | Complies |
| Loss on drying | ≤1.0% | 0.12% |
| Sulphated ash | ≤0.1% | 0.04% |
| Residual solvents | Acetone ≤0.5% | 0.10% |
| Methanol ≤0.3% | None | |
| Secondary butyl alcohol ≤0.5% | None | |
| Related substance (TLC) | Lithocholic Acid: ≤ 0.1% | Complies |
| Cholic Acid: ≤ 0.5% | Complies | |
| Chenodeoxycholic Acid: ≤ 1.0% | Complies | |
| Others: ≤ 0.25% | Complies | |
| Assay | 99.0-101.0% | 99.8% |
Microbiological Tests
| Specifications | Standard | Testing Result |
| Total Plate Count /1g | 1000 MAX | 10 MAX |
| Yeast & Mould /1g | 100 MAX | 10 MAX |
| E.coli /1g | Absent | Absent |
