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Barasa Mai Girman Magunguna (PVA) don Rufin Kwamfuta | Fim Mai Tsabta, Mai Biyan Ka'idojin GMP, CDE An Yi Rijista

Maganinmu na Polyvinyl Alcohol (PVA) wani sinadari ne mai tsarki, mai narkewa cikin ruwa wanda ake amfani da shi sosai a matsayin maganin magunguna. Yana dacewa da manyan magunguna ciki har da USP-NF, EP, JP, da ChP, tare da rajistar CDE (F20209990114). PVA yana aiki a matsayin kyakkyawan wakili mai samar da fim don shafa kwamfutar hannu, mai ɗaurewa don granulation mai danshi, mai kauri don maganin ido, da kuma mai daidaita yanayi/mai daidaita yanayi a cikin nau'ikan tsari daban-daban. Yana ba da kyawawan halaye na shingen danshi, ƙarfin mannewa mai yawa, da kuma kyakkyawan kwanciyar hankali na sinadarai. Akwai shi a cikin wani ɓangare na hydrolyzed (85-89 mol%) tare da ɗanko mai sarrafawa (4.6-6.0 mPa·s don maganin 4%)An ƙera shi a ƙarƙashin kayan aikin da suka dace da GMP, wanda ya dace da amfani da magunguna ta baki, ta fata, da kuma ta ido.

    Barasa mai ɗauke da sinadarin Polyvinyl (PVA)

    Bayanin Samfuri

    Polyvinyl Alcohol (PVA) wani abu ne mai narkewar ruwa wanda aka fi sani da shi a matsayin abu mai amfani da yawa kuma mai mahimmanci a masana'antar magunguna.Ana ƙera PVA ɗinmu na masana'antu bisa ƙa'idodin GMP masu tsauri, wanda ke tabbatar da tsarki mai yawa, inganci mai daidaito, da kuma cikakken bin ƙa'idodin magunguna na duniya.

    Asalin Samfuri:

    • Sunan Sinadarai:Barasa na Polyvinyl

    • Lambar CAS:9002-89-5

    • Lambar Rijistar CDE:F20209990114

    • Bin ƙa'idodin Pharmacopoeia:ChP, USP-NF, EP, JP

    • Maki:An rage yawan sinadarin Hydrolyzed (85-89 mol%)

    • Danko (4% na maganin, 20°C):4.6-6.0 mPa·s

    Muhimman Abubuwa & Fa'idodi

    1. Kyawawan Kayayyakin Samar da Fim

    • Yana samar da fina-finai masu kauri, ƙarfi, da sassauƙa waɗanda suka dace da murfin kwamfutar hannu

    • Yana ba da kariya mai kyau daga danshi da iskar oxygen, yana ƙara kwanciyar hankali da tsawon rayuwar samfurin

    • Kyakkyawan ikon ɓoye ƙamshi

    2. Ƙarfin Ɗaurewa Mai Girma

    • Mai ɗaurewa mai inganci don yin amfani da granulation mai laushi a ƙananan yawa (2-5%)

    • Yana samar da allunan da ke da tauri mai yawa da ƙarancin jurewa

    • Yana hana rufewa, musamman a cikin manyan hanyoyin ɗaukar magunguna

    3. Aiki Mai Yawa

    • Mai kauri/tsayawadon maganin ido da hawayen roba

    • Emulsifierdon emulsions da kuma maganin shafawa na fata

    • Kayan tushedon facin gel da tsarin isar da fata ta hanyar fata

    • Tsohon Matrixdon samfuran maganin da ake bayarwa na tsawon lokaci ta baki

    • polymer mai inganta narkewadon watsawa mai ƙarfi na amorphous (wanda fasahar sarrafawa ta zamani ta kunna)

    4. Manyan Halayen Jiki

    • Polymer mara ionic tare da narkewar pH mai zaman kansa - yana tabbatar da aiki mai daidaito a duk faɗin hanyar narkewar abinci

    • Tsarin sinadarai masu karko kuma ba mai guba ba

    • Ƙarancin ɗanko yana ba da damar samun babban abun ciki mai ƙarfi a cikin dakatarwar shafi da ruwa mai narkewa, yana inganta ingancin sarrafawa

    • Babu peroxides - ya dace da APIs masu mahimmanci

    5. Tabbatar da Inganci da Bin Dokoki

    • Cikakken bin ƙa'idodi na USP-NF, EP, JP, da ChP

    • An yi rijistar CDE (F20209990114) don kasuwar Sin

    • An ƙera shi a ƙarƙashin kayan aikin da suka dace da GMP

    • Cikakken Takaddun Shaidar Bincike (COA) da aka bayar ga kowane rukuni

    • Akwai tare da tallafin Drug Master File (DMF) don fayilolin ƙa'idoji

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