Ledipasvir Actone / PVP

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API lub npe Qhov taw qhia Specification US DMF EU DMF CEP
Ledipasvir Actone / PVP HCV Hauv tsev    


Product Detail

Khoom cim npe

KHOOM PLIG

雷迪帕韦丙酮/聚维酮 Ledipasvir actone / PVP 1256388-51-8 Hauv tsev
LPWM 1   1256387-87-7 Hauv tsev
LWM 1-5   291775-59-2 Hauv tsev
LPSM 2   1129634-44-1 Hauv tsev
LPS-6   1441670-89-8 Hauv tsev

Ledipasvir acetone (GS-5885 acetone) yog cov khoom xyaw nquag ntawm Ledipasvir. Ledipasvir yog ib qho inhibitor ntawm tus kab mob siab C NS5A, nrog EC50 qhov tseem ceeb ntawm 34 pM tawm tsam GT1a thiab 4 pM tawm tsam GT1b relicon.

Hauv Vitro

Ledipasvir acetone yog suav tias yog cov khoom xyaw nquag, uas tau hloov mus rau Ledipasvir spray-dried dispersion, amorphous dawb puag.

Cia

4°C, tiv thaiv lub teeb

* Nyob rau hauv hnyav: -80°C, 6 hli; -20°C, 1 hli (tiv thaiv lub teeb)

 

Kev piav qhia

Ledipasvir acetone (GS-5885 acetone) yog cov khoom xyaw nquag ntawm Ledipasvir. Ledipasvir yog ib qho inhibitor ntawm tus kab mob siab C NS5A, nrog EC50 qhov tseem ceeb ntawm 34 pM tawm tsam GT1a thiab 4 pM tawm tsam GT1b relicon.

 

Hauv Vitro

Ledipasvir acetone yog suav tias yog cov khoom xyaw nquag, uas tau hloov mus rau Ledipasvir spray-dried dispersion, amorphous dawb puag.

 

Cia

4°C, tiv thaiv lub teeb

 

* Nyob rau hauv hnyav: -80°C, 6 hli; -20°C, 1 hli (tiv thaiv lub teeb)

 

Cov qauv tshuaj

Ledipasvir Actone

CERTIFICATE

2018 GMP-2
GMP 201811 (captopril, thalidomide thiab lwm yam)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Tsab Ntawv-201901

QUALITY MANAGEMENT

Kev tswj kom zoo 1

Tswv yim18Quality Consistency Evaluation tej yaam num uas tau pom zoo4, thiab6tej yaam num raug tso cai.

Kev tswj kom zoo 2

Advanced thoob ntiaj teb kev tswj hwm qhov system tau tso lub hauv paus ruaj khov rau kev muag khoom.

Kev tswj kom zoo 3

Kev saib xyuas zoo khiav los ntawm tag nrho lub neej voj voog ntawm cov khoom kom ntseeg tau tias qhov zoo thiab kho cov nyhuv.

Kev tswj kom zoo 4

Pab Pawg Kev Tswj Xyuas Kev Tswj Xyuas Kev Ua Haujlwm txhawb nqa qhov kev xav tau zoo thaum lub sijhawm thov thiab sau npe.

PRODUCTION MANAGEMENT

cpf5 ua
cpf6 ua

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cpf7 ua
cpf8 ua

Taiwan CVC Lub raj mis ntim kab

cpf9 ua
cpf 10

Ltalis CAM Board Ntim Kab

cpf 11

German Fette Compacting Tshuab

cpf12 ua

Nyiv Viswill Tablet Detector

cpf14-1

DCS Control Room

PARTNER

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