China High Quality Udca Ursodeoxycholic Acid, Find details about China Ursodeoxycholic Acid, Udca Ursodeoxycholic Acid from High Quality Udca Ursodeoxycholic Acid
NATURE OF TEST | QUALITY STANDARD | TEST RESULTS |
CHARACTERS: | ||
-Appearance | White or almost white powder | Conforms |
-Solubility | Practically insoluble in water, freely soluble in ethanol (96 per cent), slightly soluble in acetone, practically insoluble in methylene chloride. | Conforms |
TESTS: | ||
-Melting point | About 202 ºC | 203ºC |
-Identification | - IR The spectrum obtained is similar to that of CRS | Conforms |
-Sepcific optical rotation | + 58.0~+62.0 | +61.7° |
-Sulphate Ash | ≤ 0.1 % | 0.02% |
-Related substances(TLC) | - Chenodeoxycholic Acid ≤ 1 % | < 1 % |
- Lithocholic Acid ≤ 0.1 % | not detected | |
- Cholic Acid ≤ 0.5 % | not detected | |
- any other impurity ≤ 0.25 % | not detected | |
-Loss on Drying | ≤ 1.0 % | 0.08 % |
-Heavy metal | ≤ 20 ppm | < 20 ppm |
ASSAY : | -On dry substance 99.0 %~101.0 % | 100.5% |
RESIDUAL SOLVENTS: | - Methanol ≤3000 ppm not detected | |
- Isopropanol ≤5000 ppm 2423 ppm | ||
- Ethylacetate ≤5000 ppm 40 ppm | ||
MICROBIOLOGICAL TESTS: | ||
-Total Plate Count /1 g | < 1000 | < 10 |
-Yeast & Mould /1 g | < 100 | < 10 |
-E. coli /1 g | Absent | Absent |
Name | Ursodeoxycholic acid | |
Synonyms | 3,7-Dihydroxycholan-24-oic acid; 3alpha,7beta-Dihydroxy-6beta-cholan-24-oic acid; Ursodiol |
Molecular Formula | C 24 H 40 O 4 | |
Molecular Weight | 392.58 | |
CAS Registry Number | 128-13-2 | |
EINECS | 204-879-3 |
Melting point | 203-206 ºC | |
alpha | 60 º (c=2, EtOH) | |
Water solubility | practically insoluble |