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I-Polyvinyl Alcohol (PVA) yoMgangatho weMithi yoKwaleka iiTablet | Ifilimu eHlanjululwe kakhulu, ehambelana neGMP, ebhalisiweyo yiCDE

I-Pharmaceutical Grade Polyvinyl Alcohol (PVA) yethu yi-polymer eyenziweyo ecocekileyo kakhulu, enyibilikayo emanzini esetyenziswa kakhulu njengesithako samayeza. Ihambelana ne-pharmacopoeias eziphambili kuquka i-USP-NF, i-EP, i-JP, kunye ne-ChP, enobhaliso lwe-CDE (F20209990114). I-PVA isebenza njengearhente ebalaseleyo yokwenza ifilimu yokugquma iipilisi, i-binder ye-granulation emanzi, i-thickener yezisombululo zamehlo, kunye ne-emulsifier/stabilizer kwiifomyula ezahlukeneyo. Inika iipropati zokuthintela umswakama eziphezulu, amandla aphezulu okuncamathela, kunye nozinzo oluhle kakhulu lweekhemikhali. Ifumaneka kwi-grade e-hydrolyzed inxalenye (85-89 mol%) kunye ne-viscosity elawulwayo (4.6-6.0 mPa·s yesisombululo se-4%).Yenziwe phantsi kwezibonelelo ezithobela i-GMP, ifanelekile ukusetyenziswa kwamayeza omlomo, awesikhumba, kunye nawamehlo.

    Utywala bePolyvinyl yoBuchule baMayeza (iPVA)

    Isishwankathelo seMveliso

    I-Polyvinyl Alcohol (PVA) yi-polymer eyenziweyo enyibilikayo emanzini eyaziwa ngokubanzi njengesithako esiguquguqukayo nesibalulekileyo kwishishini lamayeza.I-PVA yethu yodidi lweyeza yenziwe phantsi kwezikhokelo ezingqongqo ze-GMP, iqinisekisa ubunyulu obuphezulu, umgangatho ohambelanayo, kunye nokuthobela ngokupheleleyo imigangatho ye-pharmacopoeia yamazwe ngamazwe.

    Ubume beMveliso:

    • Igama leKhemikhali:Utywala bePolyvinyl

    • Inombolo ye-CAS:9002-89-5

    • Inombolo yoBhaliso lwe-CDE:F20209990114

    • Ukuthobela i-Pharmacopoeia:I-ChP, i-USP-NF, i-EP, i-JP

    • Inqanaba:I-Hydrolyzed Ngokuyinxenye (85-89 mol%)

    • Ukuqina (isisombululo se-4%, 20°C):4.6-6.0 mPa·s

    Iimpawu eziphambili kunye neenzuzo

    1. Iimpawu Ezibalaseleyo Zokwenza Iifilimu

    • Yenza iifilimu ezixineneyo, ezomeleleyo, neziguquguqukayo ezifanelekileyo zokugquma iithebhulethi

    • Ibonelela ngokhuseleko oluphezulu lokufuma kunye nokuthintela ioksijini, iphucula uzinzo lwemveliso kunye nexesha layo lokuphelelwa.

    • Ubuchule obuhle bokufihla ivumba

    2. Amandla aphezulu okuBopha

    • Isibopheleli esisebenzayo kwi-granulation emanzi kumanqanaba aphantsi (2-5%)

    • Ivelisa iipilisi ezinobunzima obuphezulu kunye nokungaguquguquki kakhulu

    • Ithintela ukuvaleka kwesikhumba, ingakumbi kwimixube yamayeza amaninzi

    3. Ukusebenza ngeendlela ezahlukeneyo

    • Isiqinisi/isiqinisikwizisombululo zamehlo kunye nokukrazula okwenziweyo

    • Isithambisi-mvelisokwi-emulsions kunye ne-topical formulations

    • Izinto ezisisisekokwiipatches zejeli kunye neenkqubo zokuhambisa i-transdermal

    • I-Matrix yangaphambilikwiifom zedosi yomlomo ekhutshwa rhoqo

    • I-polymer ephucula ukunyibilikaukusasazwa okuqinileyo okungenasimo (okuvunyelaniswa ziiteknoloji zokucubungula eziphambili)

    4. Iimpawu Eziphezulu Zomzimba

    • I-polymer engeyiyo i-ionic enokunyibilika okungena-pH- iqinisekisa ukusebenza rhoqo kwindlela yokugaya ukutya

    • Izinzile ngokweekhemikhali kwaye ayinabungozi

    • I-viscosity ephantsi ivumela umxholo ophezulu oqinileyo kwii-coating suspensions kunye ne-granulation fluids, nto leyo ephucula ukusebenza kakuhle kokucubungula

    • Akukho peroxides – ifanelekile kwii-API ezinobuthathaka

    5. Ukuthobela iMithetho kunye noQinisekiso loMgangatho

    • Ihambelana ngokupheleleyo ne-USP-NF, EP, JP, kunye nee-ChP monographs

    • I-CDE ibhalisiwe (F20209990114) kwimarike yaseTshayina

    • Yenziwe phantsi kwezibonelelo ezithobela i-GMP

    • Isatifikethi esipheleleyo soHlalutyo (i-COA) sinikezelwa kwibhetshi nganye

    • Ifumaneka ngenkxaso yeDrug Master File (DMF) kwiifayile zomthetho

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