Iimveliso
I-Ursodeoxycholic Acid (UDCA) ye-Deebio yoNyango lweGallstones
Iinkcukacha
1. Abalinganiswa: Umgubo omhlophe;engenavumba.Le mveliso inyibilika kwi-ethanol, kodwa ayinyibiliki kwi-chloroform;Inyibilika kwiglacial acetic acid, kwaye inyibilika kwisisombululo sovavanyo lwesodium hydroxide.
2. Inkqubo: Synthetic.
3. Izibonakaliso kunye nokusetyenziswa: Kunyango lwe-gallstones, isifo sesibindi se-cholestatic, isibindi esinamafutha, iintlobo ezahlukeneyo ze-hepatitis, izifo zesibindi ezinobuthi, i-cholecystitis, i-cholecystitis kunye ne-biliary dyspepsia, i-bile reflux gastritis, njl.
Kutheni sisi?
·Iveliswe kwiworkshop yeGMP
· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D
·Imathiriyeli ekrwada iyalandeleka
·Thobela umgangatho wabathengi kunye neshishini
·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla
·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.
Inkcazo
| Izinto zovavanyo | Ngokomgangatho wangaphakathi kunye noMgangatho woMthengi | |
| INKCAZELO | Umgubo omhlophe okanye phantse omhlophe. | |
| UDIDI LOKUnyibilika | Phakathi kwama-200°C kunye nama-205°C | |
| UKUJONGANA OKUTHILE | +57.0 〜+62.0 ° | |
| Ilahleko EKOMISENI | ≤0.5% | |
| INKCAZO EKUTSHENI | ≤0.1% | |
| UVAVANYO | 98.5%〜101.5% (Into eyomileyo) | |
| PURITY (HPLC) | ≥98.5% | |
| IXESHA ELIXHUMANENEYO (HPLC) | ≤1.5% (Chenodeoxycholicacid) | Ayifunyaniswanga |
| ≤0.1% (ubumdaka obungachazwanga) | 0.05% | |
| ≤0.1% (Lithocholicacid) | Ayifunyaniswanga | |
| ≤1.5% (Itotali) | 0.10% | |
| IXESHA ELIDLULEKELEYO (TLC) | ≤O.05% (i-Lithocholic acid) | Iyahambelana |
| ≤1.5% (Chenodeoxycholicacid) | Iyahambelana | |
| ISAZISO SOLUHLULU | IAcetone: ≤5000ppm | |
| IYONKE I-AEROBIC MICROBIAL COUNT | ＜103cfu/g | |
| IYELE ELIDIKISWEYO ELIDIKISWEYO/UKUMBUMBA | ＜102cfu/g | |
| E.COLI | Iyahambelana | |
| SALMONELLAE | Iyahambelana | |
| ISIPHELO | Ufanelekile | |
