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Tshuaj Qib Polyvinyl Cawv (PVA) rau Kev Txheej Txheem Ntsuas Tshuaj | Cov Yeeb Yaj Kiab Uas Muaj Kev Ntshiab Siab, Ua Raws Li GMP, Sau Npe CDE

Peb Cov Tshuaj Polyvinyl Cawv (PVA) yog ib qho polymer uas muaj kev ntshiab siab, yaj tau hauv dej uas siv dav ua ib qho tshuaj ntxiv rau hauv tshuaj. Nws ua raws li cov tshuaj pharmacopoeias tseem ceeb xws li USP-NF, EP, JP, thiab ChP, nrog rau kev sau npe CDE (F20209990114). PVA ua haujlwm ua tus neeg sawv cev zoo heev rau kev txheej ntsiav tshuaj, cov khoom sib txuas rau cov khoom ntub, cov khoom ua kom tuab rau cov tshuaj qhov muag, thiab cov emulsifier/stabilizer hauv ntau yam qauv. Nws muaj cov khoom tiv thaiv dej noo zoo dua, lub zog nplaum siab, thiab kev ruaj khov tshuaj zoo heev. Muaj nyob rau hauv qib hydrolyzed ib nrab (85-89 mol%) nrog kev tswj viscosity (4.6-6.0 mPa·s rau 4% kua).Tsim tawm raws li cov chaw ua haujlwm GMP, tsim nyog rau kev siv tshuaj hauv qhov ncauj, sab nraud, thiab qhov muag.

    Tshuaj Qib Polyvinyl Cawv (PVA)

    Txheej Txheem Cej Luam Khoom

    Polyvinyl Cawv (PVA) yog cov polymer synthetic uas yaj tau hauv dej uas paub dav tias yog cov khoom siv ntau yam thiab tseem ceeb hauv kev lag luam tshuaj.Peb cov tshuaj PVA yog tsim tawm raws li cov lus qhia GMP nruj, ua kom muaj kev ntshiab siab, zoo sib xws, thiab ua raws li cov qauv tshuaj thoob ntiaj teb.

    Lub Npe Khoom:

    • Lub Npe Tshuaj:Cawv Polyvinyl

    • Tus lej CAS:9002-89-5

    • Tus lej rau npe CDE:F20209990114

    • Kev Ua Raws Cai ntawm Pharmacopoeia:ChP, USP-NF, EP, JP

    • Qib:Ib Feem Hydrolyzed (85-89 mol%)

    • Viscosity (4% kua, 20 ° C):4.6-6.0 mPa·s

    Cov Nta Tseem Ceeb & Cov Txiaj Ntsig

    1. Cov Khoom Siv Zoo Tshaj Plaws rau Kev Tsim Yeeb Yaj Kiab

    • Tsim cov zaj duab xis ntom ntom, muaj zog, thiab yoog tau zoo tagnrho rau kev txheej ntsiav tshuaj

    • Muab kev tiv thaiv dej noo thiab cov pa oxygen zoo dua, txhim kho kev ruaj khov ntawm cov khoom thiab lub neej txee

    • Muaj peev xwm ua kom tsw ntxhiab zoo

    2. Muaj zog khi siab

    • Cov khoom siv zoo rau kev sib xyaw ua ke ntawm cov dej ntub ntawm qhov concentration qis (2-5%)

    • Tsim cov ntsiav tshuaj uas muaj qhov nyuaj siab thiab tsis yooj yim tawg

    • Tiv thaiv kev capping, tshwj xeeb tshaj yog nyob rau hauv cov tshuaj ntau ntau

    3. Kev Ua Haujlwm Ntau Yam

    • Cov khoom ua kom tuab/kho kom ruaj khovrau cov tshuaj pleev qhov muag thiab kua muag dag

    • Cov khoom ua kom emulsifierrau cov emulsions thiab cov tshuaj pleev ib ce

    • Cov khoom siv hauv pausrau cov gel thaj ua rau thaj thiab cov txheej txheem xa khoom transdermal

    • Tus qub Matrixrau cov ntawv qhia tshuaj noj uas tso tawm tas mus li

    • Cov polymer uas ua kom yaj tau zoorau cov khoom tawg amorphous (ua haujlwm los ntawm cov thev naus laus zis ua tiav siab heev)

    4. Cov Khoom Siv Zoo Tshaj Plaws

    • Cov polymer uas tsis yog ionic nrog pH-independent solubility - ua kom muaj kev ua haujlwm zoo sib xws thoob plaws txoj hnyuv plab thiab txoj hnyuv.

    • Chemically ruaj khov thiab tsis muaj tshuaj lom

    • Qhov viscosity qis ua rau muaj cov khoom khov ntau hauv cov tshuaj pleev xim thiab cov kua granulation, txhim kho kev ua haujlwm zoo

    • Tsis muaj peroxides - tsim nyog rau cov APIs rhiab heev

    5. Kev Ua Raws Cai thiab Kev Ntsuam Xyuas Zoo

    • Ua raws li USP-NF, EP, JP, thiab ChP monographs tag nrho

    • CDE sau npe (F20209990114) rau kev lag luam hauv Suav teb

    • Tsim tawm raws li cov chaw ua haujlwm GMP

    • Daim Ntawv Pov Thawj Kev Tshawb Fawb (COA) muab nrog txhua pawg

    • Muaj kev txhawb nqa nrog Drug Master File (DMF) rau cov ntaub ntawv tswj hwm

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