I-Pharmaceutical Grade Polyvinyl Alcohol (PVA) Yokumboza Amathebulethi | I-High Purity Film Former, i-GMP Compliant, i-CDE Registered

I-Pharmaceutical Grade Polyvinyl Alcohol yethu (i-PVA) iyi-polymer yokwenziwa ehlanzekile kakhulu, encibilika emanzini esetshenziswa kabanzi njengesithako semithi. Ihambisana nemithi emikhulu efaka phakathi i-USP-NF, i-EP, i-JP, ne-ChP, ene-CDE registration (F20209990114). I-PVA isebenza njenge-ejenti enhle kakhulu yokwakha ifilimu yokugqoka ithebhulethi, i-binder ye-granulation emanzi, i-thickener yezixazululo zamehlo, kanye ne-emulsifier/stabilizer ekwakhiweni okuhlukahlukene. Inikeza izakhiwo zokuvimbela umswakama eziphakeme, amandla aphezulu okunamathela, kanye nokuqina kwamakhemikhali okuhle kakhulu. Itholakala ebangeni elingama-hydrolyzed kancane (85-89 mol%) nge-viscosity elawulwayo (4.6-6.0 mPa·s yesisombululo esingu-4%).Yenziwe ngaphansi kwezikhungo ezihambisana ne-GMP, ifanele ukusetshenziswa kwemithi yomlomo, yesikhumba, kanye neyesikhumba.

Xhumana nathi

Imininingwane Yomkhiqizo

I-Pharmaceutical Grade Polyvinyl Alcohol (PVA)

Ukubuka Konke Komkhiqizo

I-Polyvinyl Alcohol (i-PVA) iyi-polymer yokwenziwa encibilika emanzini eyaziwa kabanzi njengesithako esiguquguqukayo nesibalulekile embonini yezemithi.I-PVA yethu yezinga lemithi ikhiqizwa ngaphansi kweziqondiso eziqinile ze-GMP, iqinisekisa ubumsulwa obuphezulu, ikhwalithi ehambisanayo, kanye nokuhambisana ngokugcwele nezindinganiso zamazwe ngamazwe ze-pharmacopoeia.

Ubunikazi Bomkhiqizo:

Igama Lekhemikhali:Utshwala be-Polyvinyl
Inombolo ye-CAS:9002-89-5
Inombolo Yokubhalisa ye-CDE:F20209990114
Ukuthobela Imithetho Ye-Pharmacopoeia:I-ChP, i-USP-NF, i-EP, i-JP
Izinga:Kufakwe i-Hydrolysis kancane (85-89 mol%)
Ukuqina (isixazululo esingu-4%, 20°C):4.6-6.0 mPa·s

Izici Eziyinhloko Nezinzuzo

1. Izakhiwo Ezinhle Kakhulu Zokwenza Amafilimu

Yakha amafilimu aqinile, aqinile, futhi aguquguqukayo afanelekela ukumbozwa kwethebhulethi
Inikeza ukuvikelwa okuphezulu komswakama kanye nesithiyo se-oxygen, okuthuthukisa ukuzinza komkhiqizo kanye nesikhathi sokuphelelwa yisikhathi
Ikhono elihle lokufihla iphunga

2. Amandla Okubopha Aphezulu

Isibambi esisebenzayo sokuhlanganiswa kwe-wet granulation ngamanani aphansi (2-5%)
Ikhiqiza amaphilisi anobulukhuni obuphezulu kanye nokungaguquguquki okuphansi
Kuvimbela ukuvaleka kwesikhumba, ikakhulukazi ekwakhiweni kwemithi eningi

3. Ukusebenza Okuguquguqukayo

Isiqinisi/isiqinisingezixazululo zamehlo kanye nokudabuka kokwenziwa
I-Emulsifierye-emulsions kanye ne-topical formulations
Izinto eziyisisekeloama-patches e-gel kanye nezinhlelo zokulethwa kwe-transdermal
I-matrix yangaphambiliamafomu omthamo womlomo okhululwa njalo
I-polymer ethuthukisa ukuncibilikakokuhlakazeka okuqinile okungaguquki (kunikwe amandla ubuchwepheshe obuthuthukisiwe bokucubungula)

4. Izakhiwo Eziphakeme Zomzimba

I-polymer engeyona i-ionic enokuncibilika okungaxhomeki ku-pH - iqinisekisa ukusebenza okulinganayo kulo lonke umgudu wokugaya ukudla
Ukuqina kwamakhemikhali futhi akunabo ubuthi
I-viscosity ephansi ivumela okuqukethwe okuphezulu okuqinile ekumisweni kokumboza kanye noketshezi lwe-granulation, okuthuthukisa ukusebenza kahle kokucubungula
Awekho ama-peroxide – afanele ama-API abucayi

5. Ukuthobela Imithetho Nokuqinisekiswa Kwekhwalithi

Ihambisana ngokugcwele ne-USP-NF, EP, JP, kanye ne-ChP monographs
I-CDE ibhalisiwe (F20209990114) emakethe yaseShayina
Kwenziwe ngaphansi kwezikhungo ezithobela i-GMP
Isitifiketi Esiphelele Sokuhlaziya (i-COA) esinikezwa yiqoqo ngalinye
Itholakala ngokusekelwa kwe-Drug Master File (DMF) ukuze kufakwe amadokhumenti asemthethweni