Ursodeoxycholic Acid, UDCA
1. Standard: USP, EP, CP
2. Assay: 99% (on dry basis)
3. Packin: 25kgs/drum
4. GMP
Ursodeoxycholic acid (UDCA), also known as ursodiol, is a compound produced from bile by the action of intestinal bacteria. Since this bile acid is not produced directly by the body, it is known as a secondary bile acid. One of the functions of bile acids is to act in the intestine to help digest fats and fat-soluble vitamins from food. Ursodeoxycholic acid has been used in pharmacology to dissolve gallstones made of cholesterol, and to treat liver disorders. It has been used for a long time in both human and veterinary medicine.
Ursodeoxycholic Acid EP6
| 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 |
Package: 25kg/drum, or as your request.
Storage Situation: Stored in a cool and dry well-closed container. Keep away from moisture and strong light/heat.
Shelf Life: Two years when properly stored.
Delivery: Within two weeks after receiving your prepayment.
Service we can provide:
1. Mixed container, we can mix different items in one container.
2. Quality control, before shipment, free sample for test. After shipment, keep sample for 3 years
3. Prompt shipment with professional documents
4. Packing as your request, with photo before shipment.
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To get more information, just feel free to contact with us. Thanks.
Mr. Liu
Qingdaofraken international trading Co., Ltd
Address: RM1005 post mansion yan'an three road, qingdao, China
Tel: 0086 532 83899718
Fax: 0086 532 83623236
Web: http://fraken.en.made-in-china.com/
| 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 |
Audited Supplier 
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