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Imveliso

I-Ursodeoxycholic acid 128-13-2 Inkqubo yokugaya ukutya kweCholagogic

Inkcazelo emfutshane:

Izithethantonye:iTauroursodiol;UDCA

Inombolo yeCAS:128-13-2

Umgangatho:EP10

Ifomula yemolekyuli:C24H40O4

Ubunzima beFomula:392.57


Iinkcukacha zeMveliso

Iithegi zeMveliso

Intlawulo:T/T, L/C
Imvelaphi yeMveliso:eTshayina
Indawo yokuthumela ngenqanawa:Beijing/Shanghai/Hangzhou
Umthamo wemveliso:2000kg/ngenyanga
Umyalelo(MOQ):25kg
Ixesha lokukhokhela:Iintsuku zokusebenza ezi-3
Imeko yokugcina:Igcinwe kwindawo epholileyo, eyomileyo, ubushushu begumbi.
Ipakethe imathiriyeli:igubu
Ubungakanani bepakethi:25kg/igubu
Ulwazi ngokhuseleko:Ayizompahla eziyingozi

Ursodeoxycholic acid

Intshayelelo

I-Ursodeoxycholic acid (UDCA), ekwabizwa ngokuba yi-ursodiol, yi-asidi ye-bile yesibini, eveliswa ebantwini kunye noninzi lwezinye iintlobo ze-metabolism yibhaktheriya yamathumbu.Idityaniswe esibindini kwezinye iintlobo, kwaye yaqala ukuchongwa kwi-bile yebhere, ephuma kwigama layo elithi Ursus.Kwifom ecocekileyo, isetyenziswe ukunyanga okanye ukukhusela izifo ezininzi zesibindi okanye i-bile ducts.

I-UDCA isetyenziswe njengonyango lwezonyango kwi-gallstone disease (cholelithiasis) kunye nodaka lwe-biliary.I-UDCA inceda ekunciphiseni i-cholesterol saturation yenyongo kwaye ikhokelela ekunyibilikeni kancinci kwe-cholesterol etyebileyo kwi-gallstones.

I-UDCA inokunikwa emva kotyando lwe-bariatric ukunqanda i-cholelithiasis, edla ngokwenzeka ngenxa yokuncipha ngokukhawuleza kobunzima obuvelisa i-biliary cholesterol oversaturation kunye ne-biliary dyskinesia utshintsho lwehomoni yesibini.

Iinkcukacha (EP10)

Into

Inkcazo

Imbonakalo

Umgubo omhlophe okanye phantse omhlophe

Ukunyibilika

Ayinyibiliki ngokupheleleyo emanzini, inyibilika ngokukhululekileyo kwi-ethanol (96%), inyibilika kancinane kwi-acetone, ayinyibiliki kwi-methylene chloride.

Indawo yokunyibilika

202-204℃

Ukuchongwa

I-spectrum ye-IR efanayo ne-ursodeoxycholic acid CRS
Indawo ephambili kwichromatogram efunyenwe ngesisombululo sovavanyo (b) iyafana kwindawo, umbala kunye nobukhulu kwindawo yomgaqo kwichromatogram efunyenwe ngesisombululo sereferensi (a).
Ukumiswa okufunyenweyo kuluhlaza-blue.
Ukujikeleza okuthe ngqo

+58.0 ~ + 62.0 °

Ukungcola C

I-Lithocholic acid ≤ 0.1%

Izinto eziyeleleneyo (HPLC)

ukungcola A: i-chenodeoxycholic acid ≤ 1.0%

ukungcola okungachazwanga ≤ 0.1%

iyonke ≤ 1.5%

Iintsimbi ezinzima

ICH Q3D

Ilahleko ekomisweni

≤ 1.0%

Uthuthu lwesulphate

≤ 0.1%

Isivavanyi

99.0%~101% (Into eyomileyo)

Izinyibilikisi ezishiyekileyo

I-acetone ≤ 5000 ppm

I-Ethyl acetate ≤ 5000 ppm

Isopropanol ≤ 5000 ppm

I-Ethanol ≤ 5000 ppm

Iimvavanyo zeMicrobiological

Ubalo olupheleleyo lwe-aerobic microbial ≤ 10³CFU/g

Iyonke igwele kunye nokungunda kubalwa ≤ 10²CFU/g

I-Escherichia coli: Ayikho kwi-1 g

I-Salmonella: Ayikho kwi-10 g

Iipropati ezongezelelweyo  
Ukuhanjiswa kobungakanani besuntswana

I-100% yokupasa inombolo ye-180 yesihluzo (i-100% idlule i-80 mesh sieve)


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