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ʻO ka Polyvinyl Alcohol (PVA) Papa Lāʻau Lapaʻau no ka Uhi ʻana i nā Papa | Mea Hana Kiʻiʻoniʻoni Maʻemaʻe Kiʻekiʻe, Kūpono GMP, Kāinoa ʻia ʻo CDE

ʻO kā mākou Pharmaceutical Grade Polyvinyl Alcohol (PVA) he polymer synthetic maʻemaʻe kiʻekiʻe, hoʻoheheʻe ʻia i ka wai i hoʻohana nui ʻia ma ke ʻano he excipient lāʻau lapaʻau. Kūlike ia me nā pharmacopoeias nui e like me USP-NF, EP, JP, a me ChP, me ka hoʻopaʻa inoa CDE (F20209990114). Hana ʻo PVA ma ke ʻano he mea hana kiʻiʻoniʻoni maikaʻi loa no ka uhi ʻana i nā papa, ka mea hoʻopaʻa no ka granulation pulu, ka mea hoʻomānoanoa no nā hopena ophthalmic, a me ka emulsifier/stabilizer i nā ʻano hana like ʻole. Hāʻawi ia i nā waiwai pale makū kiʻekiʻe, ka ikaika hoʻopili kiʻekiʻe, a me ke kūpaʻa kemika maikaʻi loa. Loaʻa i ka papa hydrolyzed hapa (85-89 mol%) me ka viscosity i kāohi ʻia (4.6-6.0 mPa·s no ka hopena 4%)Hana ʻia ma lalo o nā hale hana GMP-compliant, kūpono no nā noi lāʻau lapaʻau waha, topical, a me ka ophthalmic.

    ʻO ka Polyvinyl Alcohol (PVA) Papa Lāʻau Lapaʻau

    ʻIke Huahana

    ʻO ka Polyvinyl Alcohol (PVA) kahi polymer synthetic wai-soluble i ʻike nui ʻia he excipient versatile a koʻikoʻi hoʻi i ka ʻoihana lāʻau lapaʻau.Hana ʻia kā mākou PVA lāʻau lapaʻau ma lalo o nā kulekele GMP paʻa, e hōʻoiaʻiʻo ana i ka maʻemaʻe kiʻekiʻe, ka maikaʻi kūlike, a me ka hoʻokō piha ʻana me nā kūlana pharmacopoeia honua.

    ʻIke Huahana:

    • Inoa Kemika:ʻAlakō Polyvinyl

    • Helu CAS:9002-89-5

    • Helu Hoʻopaʻa Inoa CDE:F20209990114

    • Hoʻokō ʻana i ka Pharmacopoeia:ChP, USP-NF, EP, JP

    • Papa:Hoʻokahe hapa ʻia (85-89 mol%)

    • Ka mānoanoa (4% hopena, 20°C):4.6-6.0 mPa·s

    Nā Hiʻohiʻona Koʻikoʻi a me nā Pōmaikaʻi

    1. Nā Waiwai Hana Kiʻiʻoniʻoni Maikaʻi Loa

    • Hoʻokumu i nā ʻili ʻili mānoanoa, ikaika, a palupalu hoʻi kūpono no ka uhi ʻana i nā papa

    • Hāʻawi i ka pale ʻana i ka makū a me ka oxygen, e hoʻonui ana i ka paʻa o ka huahana a me ke ola papa

    • Ka hiki ke uhi ʻala maikaʻi

    2. Ikaika Hoʻopaʻa Kiʻekiʻe

    • Mea hoʻopaʻa kūpono no ka granulation pulu ma nā ʻano haʻahaʻa (2-5%)

    • Hana i nā papa me ka paʻakikī kiʻekiʻe a me ka friability haʻahaʻa

    • Kāohi i ka capping, ʻoiai i nā ʻano hana lāʻau kiʻekiʻe

    3. Hana like ʻole

    • Mea hoʻomānoanoa/mea hoʻopaʻano nā hopena ophthalmic a me nā waimaka hana

    • Mea hoʻohuihuino nā emulsions a me nā ʻano hana topical

    • Mea kumuno nā ʻāpana gel a me nā ʻōnaehana hoʻouna transdermal

    • Matrix muano nā ʻano lāʻau waha hoʻokuʻu mau ʻia

    • Polymer hoʻonui i ka solubilityno nā hoʻopuehu paʻa amorphous (i hiki ke hoʻāla ʻia e nā ʻenehana hana holomua)

    4. Nā Waiwai Kino Kiʻekiʻe Loa

    • ʻO ka polymer non-ionic me ka solubility pH-independent - hōʻoia i ka hana mau ma waena o ka ʻōpū gastrointestinal

    • Paʻa kemika a ʻaʻohe ʻawahia

    • ʻO ka viscosity haʻahaʻa e hiki ai i ka ʻike paʻa kiʻekiʻe i loko o nā suspensions coating a me nā wai granulation, e hoʻomaikaʻi ana i ka pono hana

    • ʻAʻohe peroxides - kūpono no nā API koʻikoʻi

    5. Hoʻokō kānāwai a me ka hōʻoia maikaʻi

    • Hoʻokō piha me nā monographs USP-NF, EP, JP, a me ChP

    • Ua hoʻopaʻa inoa ʻia ʻo CDE (F20209990114) no ka mākeke Kina

    • Hana ʻia ma lalo o nā hale hana GMP-compliance

    • Palapala Hōʻoiaʻiʻo Piha (COA) i hāʻawi ʻia me kēlā me kēia pūʻulu

    • Loaʻa me ke kākoʻo ʻana o ka Drug Master File (DMF) no nā waihona hoʻoponopono

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