I-Silicon Dioxide Yezinga Le-USP-NF Yezinga Lokuxubha Amazinyo
I-Silicon Dioxide Yezinga Le-USP-NF Yezinga Lokuxubha Amazinyo
I-Silicon Dioxide Yezinga Le-USP-NF Yezinga Lokuxubha Amazinyo
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I-Zhongqi Guangdong Silicon Material Co., Ltd. 1. Uhlolojikelele Lwenkampani I-Zhongqi Guangdong Silicon Material Co., Ltd. iyinkampani kazwelonke yezobuchwepheshe obuphakeme kanye neyebangeni lesifundazwe "Ezikhethekile, Ezihluziwe, Eziyingqayizivele Nezintsha" enolwazi olujulile lweminyaka engaphezu kwengu-20 embonini ye-silica. Izinze eGuangdong, eChina, sigxile ocwaningweni, ekukhiqizeni nasekuhlinzekeni emhlabeni wonke kwe-high-purity amorphous precipitated silica (i-silicon dioxide, i-SiO₂, eyaziwa nangokuthi i-white carbon black), sisebenzela imikhakha eyisithupha eyinhloko: ukudla, izimonyo, ukunakekelwa komlomo, ifidi, imithi kanye nezicelo zezimboni. Iphothifoliyo yethu ephelele yemikhiqizo ihlanganisa amazinga ajwayelekile kanye nokwakheka okwenziwe ngokwezifiso, i-pharmaceutical-grade silica ihambisana ngokugcwele nezindinganiso ezinkulu zomhlaba ze-pharmacopoeia kuhlanganise ne-USP-NF, i-Ph.Eur., i-BP ne-JP ukuze yamukelwe emhlabeni wonke ngokwezimithethonqubo. Sisekelwa amalungelo obunikazi ayi-17, indawo yokukhiqiza eqinisekisiwe nge-GMP kanye nohlelo oluqinile lokuhlola ikhwalithi olunezinyathelo ezingama-26 kusukela ekutholeni izinto zokusetshenziswa kuze kube ukukhishwa komkhiqizo ophelile, siletha izixazululo ze-silica ezihambisanayo, ezilandelwayo neziphethe kahle kumakhasimende eSoutheast Asia, eYurophu, eMelika nakwezinye izifunda zomhlaba. 2. Izinzuzo Eziyinhloko Zobuchwepheshe Imikhiqizo yethu ye-precipitated silica yakhelwe ukuhlangabezana nezindinganiso eziqine kakhulu zomhlaba zekhwalithi nokusebenza, iletha ukusebenza okuthembekile kuzo zonke izimo zokusebenza: Inzuzo Eyinhloko Incazelo Eningiliziwe Ukulawulwa Kwezinsimbi Ezisindayo Eziphansi Kakhulu Nokungcola Izinsalela zezinsimbi ezisindayo zilawulwa ngokuqinile ukuba zibe ngaphansi kakhulu kwemikhawulo ye-pharmacopoeia yomhlaba; kuvimbela ngempumelelo ukuguquka kombala okubangelwa ukusabela kwe-iron ion nezakhi ezinjenge-ethyl maltol ekudleni nasekwenziweni kwemithi, kuvikela ukubukeka komkhiqizo nokuphepha kwe-toxicological. Ukuhlanzeka Okuphezulu Nokungaguquguquki Kwebhajethi Ukulawulwa kwenqubo okuqinile okuvaliwe kunciphisa ukungcola okusele; ukufana okuqinile phakathi kwamabhajethi kuqinisekisa ukusebenza okuzinzile kuzo zonke izimboni, kuhlangabezana ngokugcwele nezimfuneko zokuhlanzeka ze-USP-NF, i-Ph.Eur., i-BP ne-JP. Ukusebenza Okuphezulu Okunezinhlangothi Eziningi Kuletha ukuthuthuka okungaphezu kuka-40% ekugelezeni kwe-powder (umphumela wokuvimbela ukubumba / i-glidant), ngezici ezinhle zokujiya, zokufiphaza, zokugqwayiza, zokumunca nokumisa ezilungiselelwe izidingo ezahlukene zokwakheka. Ukucaciswa Komkhiqizo Okwenziwa Ngokwezifiso Usayizi wezinhlayiya olungisekayo kusukela ku-2 μm kuya ku-50 μm ngokusatshalaliswa kosayizi wezinhlayiya okulawulwayo, indawo engaphezulu nokuba nezimbotshana; kutholakala nge-light grade, i-dense grade, i-hydrophilic ne-hydrophobic surface-modified variants ukuze kuhlangabezane nezidingo ezithile zokusebenza. Ukuzinza Okuhle Kokushisa Nokukhanya Kwe-UV Kumelana nokuphuzi nokonakala ngaphansi kokucubungula okushisayo nokuchayeka ekukhanyeni isikhathi eside, kugcina ukusebenza okuzinzile emikhiqizweni elashwe ngokushisa nasezicelweni zangaphandle. Ukukhiqiza Okuhambisana Ne-GMP Indawo yokukhiqiza ehlanzekile yezinga lemithi enokulandeleka okugcwele kwekhwalithi, isekela izimfuneko zokulawula ze-GMP, i-DMF ne-CEP ze-pharmaceutical excipients. 3. Izixazululo Zokusebenza 3.1 Imboni Yezokudla I-food-grade precipitated silica yethu ikhiqizwa ezingeni lokuhlanzeka elilingana ne-USP-NF, isebenza njenge-anti-caking agent esebenza kahle kakhulu yezithako zokubhaka, uswidi, izinongo, iziphuzo eziyimpuphu, izinongo zokunambitha nokunye ukudla okuyimpuphu. Iphrofayili yayo ephansi kakhulu yezinsimbi ezisindayo iqeda ukusabela kokuguquka kombala nezakhi ezibucayi ezinjenge-ethyl maltol, kuyilapho iqinisekisa ukuthotshelwa ngokugcwele kwemithethonqubo yokuphepha kokudla yomhlaba. 3.2 Izimonyo Nokunakekelwa Komuntu Siqu Ikhiqizwa ngokulawulwa kokuhlanzeka kwezinga lemithi, i-cosmetic-grade silica yethu isebenza njenge-thickener, i-matting agent, i-oil absorber kanye ne-texture enhancer emakhilimini, emalotion, kuma-serum, eziphuzwini nasezicelweni zokunakekelwa kwesikhumba. Ileta ukuzwakala kwesikhumba okubushelelezi, okusilika, i-viscosity elawulwayo nezinzwa ezinhle kakhulu, ngokuthotshelwa ngokugcwele kwe-EU CosIng, i-US CIR, i-JSCI neminye imithethonqubo yokuphepha yezimonyo yomhlaba. 3.3 Umuthi Wokuxubha Amazinyo Nokunakekelwa Komlomo I-toothpaste-grade silica yethu isebenza njenge-abrasive emnene kanye ne-thickening agent ngamanani e-RDA (Relative Dentin Abrasion) alawulwa ngokunembile. Ileta ukususwa okuphumelelayo kwe-plaque namabala ngaphandle kokulimaza uqweqwe lwamazinyo, futhi ihlangabezana nezindinganiso zamazwe ngamazwe zokunakekelwa kwamazinyo kuhlanganise ne-ADA Standard No. 25 ne-ISO 11609, ngamazinga okuhlanzeka ahambisana nezimfuneko ze-pharmacopoeia. 3.4 Imboni Yefidi I-feed-grade silica isebenza njenge-anti-caking ne-free flow agent ephumelelayo yezithako zefidi, ama-vitamin premixes, ama-mineral premixes nemikhiqizo yezondlo zezilwane. Ithuthukisa ukugeleza kwe-powder, ivimbela ukubumba ngesikhathi sokugcinwa nokuthuthwa, futhi ihambisana ne-FAMI-QS nezinye izindinganiso zokuphepha zefidi zomhlaba. 3.5 Imboni Yemithi I-pharmaceutical-grade precipitated silica yethu iyi-excipient ehlanzekile ye-amorphous ekhiqizwa ngokuqinisekisa ngokuqinile izindinganiso ze-GMP, ngokuthotshelwa ngokugcwele ama-monographs e-USP-NF, i-Ph.Eur., i-BP ne-JP. Itholakala nge-light ne-dense grades, kanye nange-hydrophilic ne-hydrophobic variants, isetshenziswa kabanzi ekwenzeni imithi yomlomo, yangaphandle neyokukhethekisa njenge-multi-functional processing aid: - I-Glidant & Anti-caking Agent: Ithuthukisa ukugeleza kwe-powder ekukhiqizeni amaphilisi nama-capsules, inciphisa ukungqubuzana phakathi kwezinhlayiya, futhi ithuthukisa ukufana kokuqukethwe kwama-active pharmaceutical ingredients (APIs). - I-Disintegrant & Adsorbent: Isheshisa ukuhlakazeka kwamaphilisi futhi ikhuthaze ukuncibilika kwe-API; futhi isebenza njengomthwali wama-API awuketshezi ukuze iwaguqule abe yizimo zomthamo eziqinile ezizinzile. - I-Thickener & Suspending Agent: Inikeza ukulawulwa kokujiya nokugeleza okuzinzile emafutheni, emakhilimini, kuma-gel nasezicelweni zangaphandle, ithuthukisa ukuthungwa komkhiqizo nokuzinza kokugcinwa. - I-Desiccant & Stabilizer: Imunca umswakamo omkhulu ezicelweni ezizwela umswakamo, inweba isikhathi sokusetshenziswa futhi igcine ukuzinza kwe-API. Sihlinzeka ngokwesekwa okugcwele kwemibhalo yokulawula kuhlanganise nama-DMF dossiers nosizo lokuqinisekiswa kwe-CEP ukuze kube lula ukubhaliswa komkhiqizo wamakhasimende ezimakethe zomhlaba zemithi. 3.6 Izicelo Zezimboni I-industrial-grade precipitated silica yethu iyinto esebenza kahle kakhulu esetshenziswa kabanzi embonini yerabha, yokupenda, yepulasitiki, kayinki nezinye izimboni ezikhethekile: Imboni Yerabha Njenge-reinforcing filler ekwakhiweni kwerabha, i-silica yethu ithuthukisa kakhulu amandla okudonsa, ukumelana nokudabuka, ukumelana nokugqwayiza nokunwebeka. Ekukhiqizeni amathayi — ikakhulukazi amathayi aluhlaza namathayi anokumelana nokugingqika okuphansi — i-silica-reinforced rubber iletha ukubamba okungcono emanzini, ukugingqika okuphansi nokusebenza kahle kukaphethiloli uma kuqhathaniswa ne-carbon black evamile. Izicelo zihlanganisa izicathulo, izimpahla zerabha zezimboni, amahose, amabhande nemikhiqizo ye-silicone rubber. Izembatho Nopende Isebenza njenge-matting agent ephumelelayo, i-anti-settling agent kanye ne-rheology modifier ekupendeni kwezakhiwo, opende bezimboni, opende bokhuni nasekuqedeleni kwezimoto. Inikeza ukuncishiswa kokucwebezela okulawulwayo, ukumelana nokuklwebheka okuthuthukisiwe, izici ezithuthukisiwe zokumelana nokugeleza phansi kanye nokuzinza okungcono kokugcinwa — ngaphandle kokunciphisa ukubonakala kopende noma ubuqotho befilimu. Amaplastiki Namafilimu Isetshenziswa njenge-anti-blocking (opening) agent kumafilimu e-polyolefin (BOPP, CPP, PE) nanjenge-reinforcing filler kumaplastiki obunjiniyela. Ithuthukisa ukubushelelezi kwendawo yefilimu, ivimbela ukuvaleka ngesikhathi sokugoqa nokugcina, futhi ithuthukisa izici zemishini ze-plastic composites. Uyinki Nokuphrinta Isebenza njenge-thickener, i-anti-settling agent kanye ne-gloss controller kuyinki yokuphrinta. Ithuthukisa ukugeleza kukayinki, ivimbela ukuhlala kwe-pigment, ithuthukisa ikhwalithi yokuphrinta, futhi inikeza ukumelana nokugqwayiza okuhle kakhulu kuzo zombili izinhlelo zikayinki ezisekelwe ku-solvent namanzi. Ukusetshenziswa Okukhethekile Kwezimboni - I-Catalyst carrier yezinqubo ze-petrochemical ne-fine chemical, ngesakhiwo se-pore nendawo engaphezulu elungisekayo - I-Filter aid ne-clarifying agent yokucubungula uketshezi lwezimboni - I-Lubricant ne-stabilizer ekucubungulweni kwe-industrial grease ne-polymer - I-Dispersant ne-defoamer carrier yezinhlelo zezimboni eziyimpuphu 4. Izindinganiso Nokuqinisekiswa Komhlaba Wonke Imikhiqizo yethu ihambisana nobubanzi obuphelele bezindinganiso nokuqinisekiswa kwamazwe ngamazwe, iqinisekisa ukwamukelwa kokulawula ezimakethe zomhlaba wonke: 4.1 Ukuphepha Kokudla - I-FSSC 22000 - I-ISO 22000:2018 - I-ISO 9001:2015 - Isitifiketi se-FDA 21 CFR - I-GB 25576-2010 (Indinganiso Yezithako Zokudla YaseChina) - Ilayisensi Yokukhiqiza Izithako Zokudla 4.2 Ukuphepha Kwefidi - I-FAMI-QS - Ilayisensi Yokukhiqiza Izithako Zefidi 4.3 Izimonyo Nokunakekelwa Komuntu Siqu - I-EU CosIng (S787) - Isitifiketi Sokuphepha Se-US CIR - I-JSCI No. 100306 (Japan) - I-China Inventory of Used Cosmetic Ingredients (No. 04867) - I-ASEAN Cosmetic Directive ehambisanayo 4.4 Ukunakekelwa kwamazinyo - I-ADA Standard No. 25 - I-ISO 11609 4.5 Izindinganiso Zezimboni Inombolo Yendinganiso Umkhiqizi Ububanzi Bokusebenza I-ISO 5794-1 I-International Organization for Standardization (ISO) Indinganiso ejwayelekile ye-precipitated hydrated silica (i-white carbon black) yezicelo zerabha I-ISO 3262-19 I-International Organization for Standardization (ISO) I-extender pigment silica yezembatho namaplastiki I-ASTM D6739 I-American Society for Testing and Materials (ASTM) Indinganiso yaseNyakatho Melika ye-silica esetshenziswa ezicelweni zerabha I-JIS K 6220 I-Japanese Industrial Standards Committee (JISC) Indinganiso yaseJapan ye-white carbon black ezicelweni zerabha I-JIS K 5101 I-Japanese Industrial Standards Committee (JISC) Indinganiso yaseJapan ye-silica esetshenziswa ezembathweni nakuma-pigment I-DIN 55923 I-German Institute for Standardization (DIN) Indinganiso yaseYurophu ye-silica ezembathweni nakuyinki yokuphrinta I-HG/T 3061 UMnyango Wezobuchwepheshe Nolwazi (China) Indinganiso yezimboni yaseChina ye-precipitated white carbon black ezicelweni zerabha 4.6 I-Pharmacopoeia Yemithi Nokuthotshelwa Kwemithethonqubo - I-USP-NF (United States Pharmacopeia – National Formulary) monograph ehambisanayo - I-Ph.Eur. (European Pharmacopoeia) monograph ehambisanayo - I-BP (British Pharmacopoeia) monograph ehambisanayo - I-JP (Japanese Pharmacopoeia) monograph ehambisanayo - Isitifiketi se-GMP sokukhiqiza i-pharmaceutical excipient - Ukwesekwa kwe-DMF (Drug Master File) dossier - Ukwesekwa kwe-CEP (Certificate of Suitability) certification 4.7 I-Halal ne-Kosher - Isitifiketi se-SHC HALAL - Isitifiketi se-OU KOSHER 4.8 Ukuthotshelwa Komphakathi - Iqinisekiswe nge-SEDEX 5. Ikhwalithi Nokukhiqiza - Isizinda sokukhiqiza esiqinisekiswe nge-GMP esinemigqa yokukhiqiza evalekile ezenzakalelayo ngokugcwele ukuze kuqedwe izingozi zokungcola okuphambanayo - Imishini yokuhlaziya ethuthukile: ama-atomic fluorescence spectrometers, ama-laser particle size analyzers, ama-BET surface area analyzers, izinhlelo zokuhlola ama-microbial nokunye - Uhlelo oluqinile lokuhlola ikhwalithi olunezinyathelo ezingama-26 oluhlanganisa ukuhlolwa kokungenayo kwezinto zokusetshenziswa, ukuqapha ngesikhathi senqubo nokuhlolwa kokukhishwa komkhiqizo ophelile, ngokulandeleka okugcwele kwebhajethi - Amandla aphelele okuhlola zonke izinkomba ze-pharmacopoeia kuhlanganise izinsimbi ezisindayo, imikhawulo yama-microbial, ukulahlekelwa kokomiswa nokusalela kokusha - I-National High-Tech Enterprise evunyiwe ngokusungula ubuchwepheshe okuqhubekayo - I-Guangdong provincial-level "Specialized, Refined, Unique and Innovative" Enterprise - Amalungelo obunikazi ayi-17 avunyiwe yi-State Intellectual Property Office 6. Ukupakishwa Nokuthutha Ukupakishwa Okujwayelekile - Usayizi: 10kg / 15kg / 20kg izikhwama ezilukiwe; imidumbu yefayibha engu-25kg yamazinga emithi - Idizayini engangeni manzi: Isikhwama se-valve se-composite film esingaphandle kwe-PE layer, noma isikhwama sangaphakathi se-PE film + isikhwama esilukiwe sepulasitiki — sivalwe ngokugcwele ekungeneni komswakamo - Inketho yezinga lemithi: Isikhwama sangaphakathi se-PE esinyumba esinezendlalelo ezimbili nomdumbu wangaphandle we-cardboard, kufaneleka imikhiqizo ye-silica yezinga elinyumba Ukugcinwa Nesikhathi Sokusetshenziswa - Gcina endaweni epholile, eyomile, enomoya omuhle - Isikhathi sokusetshenziswa: izinyanga ezingama-24 kusukela ngosuku lokukhiqizwa - Ihlukaniswa njengekhemikhali engeyona ingozi yokuthutha Ukulebula - Iphakheji ngalinye limakwe ngolwazi olugcwele olusemthethweni: izinga lomkhiqizo, ukucaciswa, imikhawulo yezithako, inombolo yelayisensi yokukhiqiza nenombolo yebhajethi - Ukulebula okwenziwe ngokwezifiso kuyatholakala ngokwezidingo zamakhasimende Ukuthutha - Ukwesekwa kokuthutha emhlabeni wonke (ngolwandle / ngomoya / ukuthutha ngezindlela eziningi) - Ukwesekwa okugcwele kwemibhalo yokuthumela ngaphandle nokuthotshelwa kwamasiko - I-supply chain evuthiwe esebenzela iSoutheast Asia, iYurophu, iMelika nasemhlabeni wonke 7. Ukwesekwa Kwamakhasimende - Ngaphambi kokuthengisa: Ukuhlinzekwa kwamahhala kwamasampula ukuze kuhlolwe ukwakheka nokuhlolwa kokuthotshelwa - Ukwesekwa kokulawula: Iphakethe eligcwele lemibhalo lokuthotshelwa kwe-pharmacopoeia, ukufakwa kwe-DMF nokubhaliswa kwemakethe - Ukwesekwa kwezobuchwepheshe: Ithimba lezobuchwepheshe elizinikele lokuhola izicelo, ukuthuthukisa ukwakheka nokuxazulula izinkinga - Ukwenziwa ngokwezifiso: Usayizi wezinhlayiya olungisekayo, indawo engaphezulu, ukwelashwa kwendawo nezixazululo zokupakisha ukuze kuhlangabezane nezidingo ezithile - Ubambiswano lwe-R&D: Ukuthuthukiswa komkhiqizo ngokuhlanganyela kwezidingo ezithile zokusebenza zamakhasimende --- I-Zhongqi Silicon Material — Umlingani Wakho Wethembekile Womhlaba Wonke Wezixazululo Ze-Silica Ehlanzeke Kakhulu Kusukela ezithako zokudla kuya kuma-pharmaceutical excipients, kusukela ekunakekelweni komuntu siqu kuya ezintweni ezithuthukile zezimboni — siletha ubuhle be-silica obuhambisana nezindinganiso eziqine kakhulu zomhlaba.
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