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Waipiro Polyvinyl (PVA) mō te Paninga Papa | Kiriata Parakore Teitei, Tutuki ki te GMP, Kua Rēhitatia ki te CDE

Ko tā mātou Waipiro Polyvinyl (PVA) he pūmua hangai tino parakore, wairewa-wai, e whakamahia whānuitia ana hei tāpiri rongoā. E rite ana ki ngā rongoā matua tae atu ki te USP-NF, EP, JP, me te ChP, me te rēhitatanga CDE (F20209990114). He pai te mahi a te PVA hei kaihanga kiriata mō te paninga papa, hei here mō te whakapūkara mākū, hei whakamātotoru mō ngā otinga kanohi, me te emulsifier/whakaū i roto i ngā momo whakatakotoranga. He pai ake ngā āhuatanga ārai makuku, he kaha piri teitei, me te pumau matū tino pai. Kei te wātea i roto i te taumata hydrolyzed wāhanga (85-89 mol%) me te matotoru whakahaere (4.6-6.0 mPa·s mō te otinga 4%).I hangaia i raro i ngā whare rongoā GMP, e tika ana mō te whakamahi ā-waha, ā-kiri, me te rongoā kanohi.

    Waipiro Polyvinyl (PVA) o te Tohu Rongoā

    Tirohanga Whānui o te Hua

    Ko te Waipiro Polyvinyl (PVA) he pūmua hangai wairewa-wai e mōhiotia whānuitia ana hei mea whakamahi maha, hei mea nui hoki i roto i te umanga rongoā.. He mea hanga ā mātou PVA kounga rongoā i raro i ngā aratohu GMP tino pakari, kia tino parakore ai, kia rite tonu te kounga, kia tutuki katoa ai ngā paerewa rongoā o te ao.

    Tuakiri Hua:

    • Ingoa Matū:Waipiro Polyvinyl

    • Tau CAS:9002-89-5

    • Tau Rēhita CDE:F20209990114

    • Te Whakatutukitanga o te Pharmacopoeia:ChP, USP-NF, EP, JP

    • Taumata:Kua Whakawaikawahia Wāhanga (85-89 mol%)

    • Te matotoru (4% otinga, 20°C):4.6-6.0 mPa·s

    Ngā Āhuatanga Matua me ngā Painga

    1. Ngā Āhuatanga Hanga Kiriata Pai rawa atu

    • He hanga kiriata matotoru, kaha, ngāwari hoki, he pai mō te paninga papa

    • Ka whakarato i te tiaki pai rawa atu i te makuku me te hāora, ka whakarei ake i te pumau me te roa o te oranga o te hua

    • He kaha pai ki te huna i te kakara

    2. Kaha Here Teitei

    • He here whai hua mō te whakapūkara mākū i ngā kukū iti (2-5%)

    • Ka whakaputa i ngā papa he tino mārō, he iti hoki te ngawari ki te pakarukaru

    • Ārai i te aukati, inā koa i roto i ngā hanganga rongoā nui

    3. Ngā Mahi Whānui

    • Whakamātotoru/whakapūmaumō ngā otinga kanohi me ngā roimata horihori

    • Kaiwhakaranumō ngā emulsion me ngā whakatakotoranga kiriuhi

    • Rauemi turangamō ngā pāti tiēre me ngā pūnaha tuku kiri

    • Matrix o muamō ngā momo horopeta ā-waha tuku-roa

    • Pūmua whakarei-wairewamō ngā marara totoka kore-āhua (e whakahohea ana e ngā hangarau tukatuka matatau)

    4. Ngā Āhuatanga Ā-tinana Pai Rawa

    • He pūhui kore-ionic me te wairewa kore-pH – ka whakarite i te mahi ōrite puta noa i te ara kai

    • He pumau te matū, ā, kāore he paitini

    • Mā te iti o te matotoru ka taea te whakanui i te nui o te totoka i roto i ngā whakatārewatanga paninga me ngā wai granulation, ka pai ake te pai o te tukatuka.

    • Kāore he peroxide – he pai mō ngā API tairongo

    5. Te Whakatutukitanga Ture me te Whakapūmau Kounga

    • He tino tutuki ki ngā tuhinga USP-NF, EP, JP, me ChP

    • Kua rēhitatia te CDE (F20209990114) mō te mākete Haina

    • I hangaia i raro i ngā whare whaimana GMP

    • Tiwhikete Tātari Whānui (COA) e whakaratohia ana me ia puranga

    • Kei te wātea me te tautoko Kōnae Matua Rongoā (DMF) mō ngā tukunga ture

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