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 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:
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Inoa Kemika:ʻAlakō Polyvinyl
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Helu CAS:9002-89-5
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Helu Hoʻopaʻa Inoa CDE:F20209990114
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Papa:Hoʻokahe hapa ʻia (85-89 mol%)
Nā Hiʻohiʻona Koʻikoʻi a me nā Pōmaikaʻi
1. Nā Waiwai Hana Kiʻiʻoniʻoni Maikaʻi Loa
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Hoʻokumu i nā ʻili ʻili mānoanoa, ikaika, a palupalu hoʻi kūpono no ka uhi ʻana i nā papa
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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
2. Ikaika Hoʻopaʻa Kiʻekiʻe
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Mea hoʻopaʻa kūpono no ka granulation pulu ma nā ʻano haʻahaʻa (2-5%)
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Hana i nā papa me ka paʻakikī kiʻekiʻe a me ka friability haʻahaʻa
3. Hana like ʻole
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Mea hoʻomānoanoa/mea hoʻopaʻano nā hopena ophthalmic a me nā waimaka hana
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Mea kumuno nā ʻāpana gel a me nā ʻōnaehana hoʻouna transdermal
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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
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ʻO ka polymer non-ionic me ka solubility pH-independent - hōʻoia i ka hana mau ma waena o ka ʻōpū gastrointestinal
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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
5. Hoʻokō kānāwai a me ka hōʻoia maikaʻi
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Ua hoʻopaʻa inoa ʻia ʻo CDE (F20209990114) no ka mākeke Kina
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Palapala Hōʻoiaʻiʻo Piha (COA) i hāʻawi ʻia me kēlā me kēia pūʻulu
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Loaʻa me ke kākoʻo ʻana o ka Drug Master File (DMF) no nā waihona hoʻoponopono










