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Alcool yo mu bwoko bwa Polyvinyl Alcohol (PVA) yo mu bwoko bwa farumasi yo gusiga ibinini | High Purity Film Former, GMP Compliant, CDE Registered

Alcool yacu ya Polyvinyl yo mu rwego rwa farumasi (PVA) ni polymeri ikoze mu buryo bw'umwimerere kandi isukura amazi ikoreshwa cyane nk'umuti ugabanya ubushyuhe. Ihuye n'ibipimo by'imiti birimo USP-NF, EP, JP, na ChP, ifite iyandikwa rya CDE (F20209990114). PVA ikora nk'ikintu cyiza cyane cyo gushushanya ibinini, ifata granulation y'amazi, igabanya ubushyuhe bw'amaso, na emulsifier/stabilizer mu buryo butandukanye. Itanga ubushobozi bwo kubuza ubushuhe, imbaraga nyinshi zo gufata neza, kandi ikagira ubuziranenge buhamye bw'imiti. Iboneka mu rwego rwa hydrolyzed igice (85-89 mol%) hamwe n'ubushyuhe bugenzurwa (4.6-6.0 mPa·s kuri 4% by'umuti)Yakozwe hakurikijwe ibikoresho bikurikiza GMP, ikwiriye gukoreshwa mu kunywesha, mu gusukura, no mu gutanga imiti y'amaso.

    Alcool yo mu bwoko bwa Polyvinyl (PVA) yo mu rwego rw'imiti

    Incamake y'ibicuruzwa

    Alcool ya Polyvinyl (PVA) ni polymer ishongesha mu mazi izwi cyane nk'ikintu cy'ingenzi kandi gikoreshwa mu nganda z'imiti.PVA yacu yo mu rwego rw'imiti ikorwa hakurikijwe amabwiriza akomeye ya GMP, igamije kugenzura ko isuku iri hejuru, ireme rihoraho, kandi ikubahiriza amabwiriza mpuzamahanga ya farumasi.

    Indangamuntu y'igicuruzwa:

    • Izina ry'ibinyabutabire:Inzoga ya Polyvinyl

    • Nimero ya CAS:9002-89-5

    • Nomero yo kwiyandikisha ya CDE:F20209990114

    • Iyubahirizwa ry'amategeko agenga farumasi:ChP, USP-NF, EP, JP

    • Icyiciro:Irimo amazi ahagije (85-89 mol%)

    • Ubushyuhe (4% by'umuti, 20°C):4.6-6.0 mPa·s

    Ibintu by'ingenzi n'inyungu

    1. Imiterere myiza cyane yo gukora filime

    • Ikora filime zikomeye, zikomeye kandi zoroshye, zikwiriye gusiga ibinini

    • Itanga uburinzi buhanitse bw'ubushuhe n'umwuka wa ogisijeni, yongera ubusugire bw'ibicuruzwa no kumara igihe kirekire

    • Ubushobozi bwiza bwo gupfuka impumuro mbi

    2. Ingufu nyinshi zo gufatanya

    • Uburyo bwiza bwo gufatanya ibintu bitose ku gipimo gito (2-5%)

    • Ikora ibinini bifite ubukana bwinshi kandi bidapfa gucika intege

    • Birinda ko imiti ifunga, cyane cyane iyo irimo imiti myinshi

    3. Imikorere inyuranye

    • Icupa/Iterambereku miti y'amaso n'amarira y'ubukorano

    • Emulsifierku miti ikoreshwa mu gusiga amavuta n'imiti ikoreshwa mu gusiga amavuta

    • Ibikoresho by'ibanzeku bipande bya gel na sisitemu zo gutanga transdermal

    • Icyahoze ari Matrixku bipimo byo kunywa birekurwa mu buryo buhoraho

    • Polima yongera ubushobozi bwo gushongaku gukwirakwiza ibintu bikomeye bidafite isura (bikoresheje ikoranabuhanga rigezweho ryo kubitunganya)

    4. Imiterere myiza y'umubiri

    • Polymeri idafite ionic ifite ubushobozi bwo gushonga mu buryo butagengwa na pH - ituma habaho imikorere ihamye mu nzira y'igifu

    • Irahamye kandi ntigira uburozi

    • Ubushyuhe buke butuma habaho ingano ikomeye mu bisigazwa byo gusiga no mu binyabutabire, bigatuma imikorere irushaho kuba myiza.

    • Nta peroxides - ikwiriye APIs zoroshye

    5. Iyubahirizwa ry'amategeko n'ubuziranenge

    • Yujuje ibisabwa byose kuri monographe za USP-NF, EP, JP, na ChP

    • CDE yanditse (F20209990114) ku isoko ry'Ubushinwa

    • Byakozwe hakurikijwe ibikoresho bikurikiza GMP

    • Icyemezo cyuzuye cy'isesengura (COA) gitangwa kuri buri cyiciro

    • Iboneka hamwe n'ubufasha bwa Drug Master File (DMF) ku nyandiko zigenzura

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