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Imveliso

Tacrolimus monohydrate 109581-93-3 Antibiotic

Inkcazelo emfutshane:

Izithethantonye:FK-506;FK506 monohydrate

Inombolo yeCAS:109581-93-3

Umgangatho:USP43

Ifomula yemolekyuli:C44H69NO12

Ubunzima beFomula:822.04


Iinkcukacha zeMveliso

Iithegi zeMveliso

Intlawulo:T/T, L/C
Imvelaphi yeMveliso:eTshayina
Indawo yokuthumela ngenqanawa:Beijing/Shanghai/Hangzhou
Umthamo wemveliso:1kg/ngenyanga
Umyalelo(MOQ):1g
Ixesha lokukhokhela:Iintsuku zokusebenza ezi-3
Imeko yokugcina:Igcinwe kwindawo epholileyo, eyomileyo, ubushushu begumbi.
Ipakethe imathiriyeli:ibhotile, ibhotile
Ubungakanani bepakethi:1g/ibhodlela, 5/ibhotile, 10g/ibhotile, 50g/ibhotile, 500g/ibhotile
Ulwazi ngokhuseleko:UN 2811 6.1/PG 3

Tacrolimus monohydrate

Intshayelelo

I-Tacrolimus, lichiza le-immunosuppressive.Emva kokufakelwa kwe-allogeneic organ, umngcipheko wokulahlwa kwelungu uphakathi.Ukunciphisa umngcipheko wokulahlwa kwelungu, i-tacrolimus inikwa.Ichiza linokuthi lithengiswe njengeyeza le-topical kunyango lwezifo ze-T-cell-mediated ezifana ne-eczema kunye ne-psoriasis.Ingasetyenziselwa ukuphatha i-syndrome yamehlo eyomileyo kwiikati kunye nezinja.

I-Tacrolimus inqanda i-calcineurin, ebandakanyekayo ekuveliseni i-interleukin-2, i-molecule ekhuthaza ukuphuhliswa kunye nokwanda kweeseli ze-T, njengenxalenye yempendulo yomzimba efundwayo (okanye i-adaptive).

Inkcazo (USP43)

Into

Inkcazo

Imbonakalo

Umgubo omhlophe okanye ophantse umhlophe wekristale

Ukuchongwa

IR, HPLC

Ukunyibilika

Inyibilika kakhulu kwi-methanol, inyibilika ngokukhululekileyo kwi-N, N dimethylformamide nakwi-alcohol, ngokuthe ngqo ekunyibilikeni emanzini.

Intsalela ekutshisweni

≤0.10 %

Ukungcola kwezinto eziphilayo

(inkqubo-2)

Ascomycin 19-epimer ≤0.10 %

Ascomycin ≤0.50 %

I-Desmethyl tacrolimus ≤0.10 %

Tacrolimus 8-epimer ≤0.15 %

Tacrolimus 8-propyl analog ≤0.15 %

Ukungcola okungaziwayo -I ≤0.10 %

Ukungcola okungaziwayo -II ≤0.10 %

Ukungcola okungaziwayo -III ≤0.10 %

Ubumdaka bubonke ≤1.00 %

Ujikelezo lwamehlo (ngokwesiseko)

(10mg/ml kwi-N,Ndimethylformamide)

-110.0 ° ~ -115.0 °

Isiqulatho samanzi (nge-KF)

≤4.0%

Izinyibilikisi ezishiyekileyo (ngu-GC)

I-acetone ≤1000ppm (Endlwini)

I-Di-isopropyl ether ≤100ppm (Endlwini)

I-ethyl ether ≤5000ppm

I-Acetonitrile ≤410ppm

Toluene ≤890ppm

Hexane ≤290ppm

Uvavanyo lweMicrobial (endlwini)

Ubalo olupheleleyo lwe-aerobic microbial ≤100cfu/gm

Iyonke igwele kunye nokubala kokungunda ≤10cfu/gm

Izinto eziphilayo ezichaziweyo (iiPathogens) (E.coil, salmonella sps., S.aureus. Pseudomonas aeruginosa) kufuneka zingabikho

Uvavanyo (nge-HPLC) (kwisiseko se-anhydrous kunye ne-solvent free basis)

98%~102%


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