I-Zhongqi Guangdong Silicon Material Co., Ltd. 1. Uhlolojikelele Lwenkampani I-Zhongqi Guangdong Silicon Material Co., Ltd. iyinkampani kazwelonke yezobuchwepheshe obuphakeme kanye neyebhizinisi lezifundazwe "Eliqondile, Elihlungiwe, Eliyingqayizivele Nelinoveli" elinolwazi olujulile lweminyaka engaphezu kwengu-20 embonini ye-silica. Izinze e-Guangdong, e-China, sigxile ekucwaningeni, ekukhiqizeni nasekuhlinzekeni emhlabeni wonke nge-precipitated silica engenamumo ehlanzekile kakhulu (i-silicon dioxide, i-SiO₂, eyaziwa nangokuthi i-white carbon black), sisebenzela imikhakha eyisithupha eyinhloko: ukudla, izimonyo, ukunakekelwa komlomo, ukudla kwezilwane, imithi kanye nezicelo zezimboni. Iphothifoliyo yethu ephelele yemikhiqizo ihlanganisa amazinga ajwayelekile kanye nokwakheka okwenziwe ngokwezifiso, ne-silica yezinga lemithi ehambisana ngokugcwele nazo zonke izindinganiso ezinkulu zomhlaba ze-pharmacopoeia kuhlanganise ne-USP-NF, Ph.Eur., BP, JP, ChP, IP, KP kanye ne-IPh, okwenza ukufinyelela emakethe kungabi nankinga kulo lonke elaseMelika, eYurophu, eJaphan, e-China, eNdiya, eNingizimu Korea nasezifundeni ezilawulwa yi-WHO. Sisekela amazinga e-pharmacopoeia eyodwa kanye nezimfuneko ezihlanganisiwe ze-pharmacopoeia ezimbili noma ezintathu ezifana ne-JP/USP, CP/USP/EP kanye ne-USP/EP/BP ukuze sihambisane nezidingo ezihlukahlukene zokulawula zesifunda. Sisekelwa amalungelo obunikazi ayi-17, indawo yokukhiqiza eqinisekisiwe ye-GMP kanye nohlelo oluqinile lokuhlola ikhwalithi olunezinyathelo ezingama-26 kusukela ekutholeni izinto zokusetshenziswa kuya ekukhishweni komkhiqizo ophelile, siletha izixazululo ze-silica ezingaguquki, ezilandelwayo nezinokusebenza okuphezulu kumakhasimende emhlabeni wonke. 2. Izinzuzo Eziyinhloko Zobuchwepheshe Imikhiqizo yethu ye-precipitated silica yakhelwe ukuhlangabezana nezindinganiso eziqine kakhulu zomhlaba zekhwalithi nokusebenza, iletha ukusebenza okuthembekile kuzo zonke izimo zokusebenzisa: Inzuzo Eyinhloko Incazelo Eningiliziwe Ukuthotsela Okugcwele Kwe-Pharmacopoeia Yomhlaba Wonke Yakhelwe ukuhambisana ne-USP-NF, Ph.Eur., BP, JP, ChP (uhlelo lwango-2025), IP, KP kanye ne-IPh monograph specifications; itholakala ngezinga elilodwa, amazinga amabili kanye namazinga amathathu ukuze kugcwaliswe izidingo zokubhaliswa kwezimakethe eziningi. Ukulawulwa Kwezinsimbi Ezisindayo Eziphansi Kakhulu Nokungcola Izinsalela zezinsimbi ezisindayo zilawulwa ngokuqinile kude kakhulu nemikhawulo ye-pharmacopoeia yomhlaba; kuvimbela ngempumelelo ukuguquka kombala okubangelwa ukusabela kwe-iron ion nezithako ezifana ne-ethyl maltol ekudleni nasekwenziweni kwemithi, kuvikela ukubukeka komkhiqizo nokuphepha kwezobuthi. Ukumbozwa Okugcwele Kokuma Komkhiqizo I-matrix ephelele yomkhiqizo ihlanganisa i-light grade, i-dense grade, i-colloidal anhydrous silica, i-hydrated silica, i-ultrafine grade, i-micron-sized grade kanye nezinye izimfuno ezenziwe ngokwezifiso, ehambisana nezidingo ezihlukahlukene zenqubo yokwakheka. Ukuhlanzeka Okuphezulu Nokungaguquguquki Kwebhajethi Ukulawulwa kwenqubo okuqinile okusemzileni ovalekile kunciphisa ukungcola okusele; ukungaguquki okuqinile phakathi kwebhajethi kuqinisekisa ukusebenza okuzinzile kuzo zonke izimboni, kugcwalise ngokugcwele zonke izimfuno zokuhlanzeka ze-pharmacopoeia ezinkulu. Ukusebenza Okuhle Kakhulu Okunezinhlangothi Eziningi Kuletha ngaphezu kuka-40% ukuthuthukiswa kokugeleza kwempushana, ngokusebenza okuhle kakhulu njenge-anti-caking agent, i-glidant, i-disintegrant, i-adsorbent, i-thickener, i-suspending agent, i-desiccant, i-stabilizer, i-dispersant kanye ne-matting agent ehambisana nezidingo ezihlukene zokwakheka. Izimfuno Zomkhiqizo Ezingenziwa Ngokwezifiso Usayizi wezinhlayiya olungisekayo kusukela ku-2 μm kuya ku-50 μm ngokusatshalaliswa kosayizi wezinhlayiya okulawulwayo, indawo engaphezulu nokungena komoya okulungisekayo, kanye nezinketho zokuguqula indawo engaphezulu ye-hydrophilic / hydrophobic ukuze kuhambisane nezidingo ezithile zokusebenzisa. Ukumelana Okuhle Kakhulu Nokushisa 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 ukufakwa kwe-GMP, DMF, CEP, CDE kanye nezinye izidingo zokulawula ze-pharmaceutical excipients. 3. Izixazululo Zokusebenzisa 3.1 Imboni Yezokudla I-food-grade precipitated silica yethu ikhiqizwa ngezinga lokuhlanzeka elilingana ne-pharmacopoeia, itholakala ngamazinga ahambisana ne-USP-NF, JP, ChP kanye ne-IP, isebenza njenge-anti-caking agent enokusebenza okuphezulu kanye ne-free flow agent yezithako zokubhaka, uswidi, izinongo, iziphuzo eziyimpushana, izinongo zokunambitha kanye nokunye ukudla okuyimpushana. Iphrofayili yayo ephansi kakhulu yezinsimbi ezisindayo iqeda ukusabela kokuguquka kombala nezithako ezibucayi ezifana ne-ethyl maltol, kuyilapho iqinisekisa ukuthotsela ngokugcwele izindinganiso zokuphepha kokudla zomhlaba. 3.2 Izimonyo Nokunakekelwa Komuntu Siqu Kukhiqizwa ngokulawulwa kokuhlanzeka kwezinga lemithi, i-cosmetic-grade silica yethu isebenza njenge-thickener, i-matting agent, i-oil absorber kanye ne-texture enhancer kumakilimu, ama-lotion, ama-serum, ama-powder kanye nokwakheka kokunakekelwa kwesikhumba. Iletha ukuzwa kwesikhumba okubushelelezi, okusilika, i-viscosity elawulwayo kanye nezakhiwo zenzwa ezinhle kakhulu, ngokuthotsela ngokugcwele i-EU CosIng, i-US CIR, i-JSCI kanye nezinye izindinganiso zokuphepha zezimonyo zomhlaba. 3.3 Umuthi Wokuxubha Amazinyo Nokunakekelwa Komlomo I-toothpaste-grade silica yethu isebenza njenge-abrasive emnene kanye ne-thickening agent ngamavelu e-RDA (Relative Dentin Abrasion) alawulwa ngokunembile. Iletha ukususwa kwamazinyo nokungcola okusebenzayo ngaphandle kokulimaza uqweqwe lwamazinyo, futhi ihlangabezana nezindinganiso zamazwe ngamazwe zokunakekelwa kwamazinyo kuhlanganise ne-ADA Standard No. 25 kanye ne-ISO 11609, ngamazinga okuhlanzeka ahambisana nezidingo ze-JP, ChP kanye nezinye ze-pharmacopoeia zesifunda. 3.4 Imboni Yokudla Kwezilwane I-feed-grade silica isebenza njenge-anti-caking kanye ne-free flow agent ephumelelayo yezithako zokudla kwezilwane, ama-vitamin premixes, ama-mineral premixes kanye nemikhiqizo yezondlo zezilwane. Ithuthukisa ukugeleza kwempushana, ivimbela ukubumba ngesikhathi sokugcina nokuthutha, futhi ihambisana ne-FAMI-QS kanye nezinye izindinganiso zokuphepha kokudla kwezilwane zomhlaba. 3.5 Imboni Yemithi I-pharmaceutical-grade precipitated silica yethu iyi-excipient engenamumo ehlanzekile kakhulu ekhiqizwa ngokuqinisekisa ngokuqinile izindinganiso ze-GMP, ngokuthotsela ngokugcwele ama-monographs e-USP-NF, Ph.Eur., BP, JP, ChP (uhlelo lwango-2025), IP, KP kanye ne-IPh pharmacopoeia. Sinikeza izimfuno eziphelele zomkhiqizo kuhlanganise ne-light grade, i-dense grade, i-colloidal anhydrous silica, i-hydrated silica, i-oral grade, i-injectable grade kanye ne-topical grade, kanye namazinga ahlanganisiwe e-pharmacopoeia amabili nantathu ukuze kusekelwe ukubhaliswa emakethe yomhlaba. Njenge-pharmaceutical excipient enezinhlangothi eziningi, isetshenziswa kabanzi ekwakhiweni komlomo, okwangaphezulu, okujovwayo kanye nokukhethekile: •I-Glidant & Anti-caking Agent: Ithuthukisa ukugeleza kwempushana ekukhiqizeni amaphilisi nama-capsule, inciphisa ukungqubuzana phakathi kwezinhlayiya, futhi ithuthukisa ukufana kokuqukethwe kwezithako ezisebenzayo (APIs). •I-Disintegrant & Adsorbent: Isheshisa ukuhlakazeka kwamaphilisi futhi ikhuthaze ukuncibilika kwe-API; futhi isebenza njengomthwali wama-API anguketshezi ukuze iwaguqule abe yizimo zomthamo eziqinile ezizinzile. •I-Thickener & Suspending Agent: Inikeza ukujiya okuzinzile nokulawulwa kwe-rheology kuma-ointment, amakilimu, ama-gel kanye nokwakheka kwangaphezulu, ithuthukisa ukuthungwa komkhiqizo nokuzinza kokugcina. •I-Desiccant & Stabilizer: Imunca umswakama omncane ekwakhiweni okuzwela umswakama, inwebe isikhathi sokusetshenziswa futhi igcine ukuzinza kwe-API. •I-Lubricant & Dispersant: Ithuthukisa ukusebenza kokucubungula impushana futhi ithuthukise ukufana kokusabalalisa kwe-API ekwakhiweni okuqinile nokweqile. Sinikeza ukusekelwa okugcwele kwemibhalo yokulawula kuhlanganise nama-DMF dossiers, isitifiketi se-CEP, ukufakwa kwe-CDE (China), ukugunyazwa kwe-CDSCO (India), ukugunyazwa kwe-MFDS (South Korea) kanye nosizo lokufaneleka kwe-WHO ukuze kube lula ukubhaliswa komkhiqizo wamakhasimende ezimakethe zomhlaba zemithi. 3.6 Izicelo Zezimboni I-industrial-grade precipitated silica yethu iyinto esebenza kahle kakhulu enezinhlangothi eziningi esetshenziswa kabanzi erabha, okokugqoka, amapulasitiki, uyinki kanye nemikhakha ekhethekile yezimboni, ngezimfuno ezihambisana ne-JP, ChP, IP kanye nezinye izindinganiso zezimboni zesifunda: Imboni Yerabha Njenge-reinforcing filler ekwakhiweni kwerabha, i-silica yethu ithuthukisa kakhulu amandla okudonsa, ukumelana nokudabuka, ukumelana nokugqokwa kanye nokunwebeka. Ekukhiqizeni amathayi — ikakhulukazi amathayi aluhlaza namathayi anokumelana nokugingqika okuphansi — irabha eqiniswe nge-silica iletha ukubamba okungcono lapho kumanzi, ukugingqika okuphansi kanye nokusebenza kahle kukaphethiloli uma kuqhathaniswa ne-carbon black yendabuko. Izicelo zihlanganisa izicathulo, izimpahla zerabha zezimboni, amahose, amabhande kanye nemikhiqizo ye-silicone rubber. Okokugqoka Nopende Isebenza njenge-matting agent ephumelelayo, i-anti-settling agent kanye ne-rheology modifier ekugqokeni kwezakhiwo, upende wezimboni, ukugqoka kokhuni kanye nokuqedwa kwezimoto. Inikeza ukuncishiswa kokucwebezela okulawulwayo, ukumelana nokuklwebheka okuthuthukisiwe, izakhiwo ezithuthukisiwe zokumelana nokugeleza phansi kanye nokuzinza kokugcina okungcono — ngaphandle kokunciphisa ukubonakala kokugqoka noma ubuqotho befilimu. Amapulasitiki Namafilimu Isetshenziswa njenge-anti-blocking (opening) agent kumafilimu e-polyolefin (BOPP, CPP, PE) nanjenge-reinforcing filler kumapulasitiki obunjiniyela. Ithuthukisa ukubushelelezi kwendawo yefilimu, ivimbela ukuvaleka ngesikhathi sokugoqa nokugcina, futhi ithuthukise izakhiwo zemishini yezinhlanganisela zepulasitiki. Uyinki Nokuphrinta Isebenza njenge-thickener, i-anti-settling agent kanye ne-gloss controller kuyinki yokuphrinta. Ithuthukisa i-rheology kayinki, ivimbela ukuhlala kwe-pigment, ithuthukise ikhwalithi yokuphrinta, futhi inikeze ukumelana nokugqokwa okuhle kakhulu kuzo zombili izinhlelo zoyinki ezisekelwe ku-solvent namanzi. Ukusetshenziswa Okukhethekile Kwezimboni •Umthwali we-catalyst wezinqubo ze-petrochemical ne-fine chemical, ngesakhiwo se-pore nendawo engaphezulu elungisekayo •I-filter aid ne-clarifying agent yokucubungula uketshezi lwezimboni •I-lubricant ne-stabilizer ekucubunguleni i-grease ye-zimboni ne-polymer •Umthwali we-dispersant ne-defoamer ezinhlelweni zezimboni eziyimpushana 4. Izindinganiso Zomhlaba Nokugunyazwa Imikhiqizo yethu ihambisana nohlu olubanzi lwezindinganiso zamazwe ngamazwe nezitifiketi, okuqinisekisa ukwamukelwa kokulawula ezimakethe zomhlaba wonke: 4.1 Ukuphepha Kokudla •FSSC 22000 •ISO 22000:2018 •ISO 9001:2015 •FDA 21 CFR attestation •GB 25576-2010 (Izinga Lokudla Okungezwayo Lase-China) •Iphepha Lokugunyaza Lokukhiqiza Ukudla Okungezwayo 4.2 Ukuphepha Kokudla Kwezilwane •FAMI-QS •Iphepha Lokugunyaza Lokukhiqiza Ukudla Okungezwayo Kwezilwane 4.3 Izimonyo Nokunakekelwa Komuntu Siqu •EU CosIng (S787) •US CIR Safety Certification •JSCI No. 100306 (Japan) •I-China Inventory of Used Cosmetic Ingredients (No. 04867) •ASEAN Cosmetic Directive compliant 4.4 Ukunakekelwa kwamazinyo •ADA Standard No. 25 •ISO 11609 4.5 Izindinganiso Zezimboni Inombolo Yezinga Umkhiqizi Wezinga Ububanzi Bokusebenzisa ISO 5794-1 International Organization for Standardization (ISO) Izinga elijwayelekile le-precipitated hydrated silica (white carbon black) yezicelo zerabha ISO 3262-19 International Organization for Standardization (ISO) I-extender pigment silica yokugqoka namapulasitiki ASTM D6739 American Society for Testing and Materials (ASTM) Izinga laseNyakatho Melika le-silica esetshenziswa ezicelweni zerabha JIS K 6220 Japanese Industrial Standards Committee (JISC) Izinga laseJaphan le-white carbon black ezicelweni zerabha JIS K 5101 Japanese Industrial Standards Committee (JISC) Izinga laseJaphan le-silica esetshenziswa ekugqokeni nase-pigments DIN 55923 German Institute for Standardization (DIN) Izinga laseYurophu le-silica ekugqokeni nakuyinki yokuphrinta HG/T 3061 Ministry of Industry and Information Technology (China) Izinga lezimboni lase-China le-precipitated white carbon black ezicelweni zerabha 4.6 I-Pharmacopoeia Yemithi Nokuthotsela Kokulawula I-pharmaceutical-grade silica yethu ihlangabezana nezidingo ze-monograph zazo zonke izincwadi ezinkulu ze-pharmacopoeia zomhlaba, ngokusekela amazinga ahlanganisiwe e-pharmacopoeia amaningi: •I-USP-NF (United States Pharmacopeia – National Formulary) monograph compliant •I-Ph.Eur. (European Pharmacopoeia) monograph compliant •I-BP (British Pharmacopoeia) monograph compliant •I-JP (Japanese Pharmacopoeia) monograph compliant •I-ChP (Chinese Pharmacopoeia) uhlelo lwango-2025 monograph compliant, ngokusekela ukufakwa kwe-CDE •I-IP (Indian Pharmacopoeia) monograph compliant, ngokusekela ukugunyazwa kwe-CDSCO •I-KP (Korean Pharmacopoeia) monograph compliant, ngokusekela ukugunyazwa kwe-MFDS •I-IPh (International Pharmacopoeia) monograph compliant, ngokusekela ukufaneleka kwe-WHO •Itholakala ngezimfuno ezihlanganisiwe: i-USP/EP dual standard, i-USP/EP/BP triple standard, i-JP/USP dual standard, i-CP/USP/EP triple standard, njll. •Isitifiketi se-GMP sokukhiqiza i-pharmaceutical excipient •Ukusekela idosi ye-DMF (Drug Master File) •Ukusekela isitifiketi se-CEP (Certificate of Suitability) 4.7 I-Halal ne-Kosher •Isitifiketi se-SHC HALAL •Isitifiketi se-OU KOSHER 4.8 Ukuthotsela 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 kanye nokuhlolwa kokukhishwa komkhiqizo ophelile, ngokulandeleka okugcwele kwebhajethi •Amandla aphelele okuhlola zonke izinkomba ze-pharmacopoeia kuhlanganise izinsimbi ezisindayo, imikhawulo yama-microbial, ukulahlekelwa kokomiswa kanye nensalela ekushisweni, okuhlanganisa izinqubo zokuhlola ze-USP-NF, Ph.Eur., BP, JP, ChP, IP, KP kanye ne-IPh •I-National High-Tech Enterprise eqinisekiswe ngokusungula ubuchwepheshe okuqhubekayo •Ibhizinisi lezifundazwe lase-Guangdong "Eliqondile, Elihlungiwe, Eliyingqayizivele Nelinoveli" •Amalungelo obunikazi agunyaziwe ayi-17 anikezwe yi-State Intellectual Property Office 6. Ukupakishwa Nokuthutha Ukupakishwa Okujwayelekile •Osayizi: 10kg / 15kg / 20kg izikhwama ezilukiwe; imigqomo yefayibha engu-25kg yamazinga emithi •Idizayini engangeni manzi: Isikhwama se-composite film valve esingqimba lwangaphandle lwe-PE, noma isikhwama sangaphakathi se-PE film + isikhwama esilukiwe sepulasitiki — sivalwe ngokugcwele ekungeneni komswakama •Inketho yezinga lemithi: Isikhwama sangaphakathi se-PE esinyumba esinezendlalelo ezimbili nomgqomo wangaphandle wekhadibhodi, elilungele imikhiqizo ye-silica e-sterile-grade ne-injectable-grade Ukugcina Nesikhathi Sokusetshenziswa •Gcina endaweni epholile, eyomile, enomoya omuhle •Isikhathi sokusetshenziswa: izinyanga ezingama-24 kusukela ngosuku lokukhiqizwa •Ihlukaniswa njengekhemikhali engeyona ingozi yokuthutha Ukulebula •Iphakethe ngalinye limakwe ngalo lonke ulwazi olusemthethweni: izinga lomkhiqizo, imininingwane, izinga le-pharmacopoeia, imikhawulo yezithako, inombolo yephepha lokugunyaza lokukhiqiza kanye nenombolo yebhajethi •Ukulebula okwenziwe ngokwezifiso kuyatholakala ngokwezidingo zamakhasimende Ukuthutha •Ukusekela ukuthutha emhlabeni wonke (ngolwandle / ngomoya / ukuthutha ngezindlela eziningi) •Amadokhumenti aphelele okuthumela ngaphandle nokusekela ukuthotsela kwamasiko •I-supply chain evuthiwe esebenzela iSoutheast Asia, iYurophu, iMelika, iNdiya, iNingizimu Korea kanye nomhlaba wonke 7. Ukusekela Amakhasimende •Ngaphambi kokuthengisa: Ukunikezwa kwamahhala kwamasampula ukuze kuhlolwe ukwakheka nokuthotsela •Ukusekela kokulawula: Iphakethe eligcwele lemibhalo lokuthotsela i-pharmacopoeia, ukufakwa kwe-DMF, ukubhaliswa kwe-CDE kanye nokubhaliswa emakethe kuzo zonke izifunda ezinkulu •Ukusekela kobuchwepheshe: Ithimba lobuchwepheshe elizinikele lokuhola izicelo, ukuthuthukisa ukwakheka nokuxazulula izinkinga •Ukwenziwa ngokwezifiso: Usayizi wezinhlayiya olungisekayo, indawo engaphezulu, ukwelashwa kwendawo engaphezulu, inhlanganisela yezinga le-pharmacopoeia kanye nezixazululo zokupakisha ukuze kuhlangabezane nezidingo ezithile •Ubambiswano lwe-R&D: Ukuthuthukiswa komkhiqizo ngokuh співпраця kwizidingo ezithile zamakhasimende I-Zhongqi Silicon Material — Umlingani Wakho Wethembekile Womhlaba Wonke Wezixazululo Ze-Silica Ehlanzekile Kakhulu Kusukela ezithako zokudla kuya kuma-pharmaceutical excipients, kusukela ekunakekeleni komuntu siqu kuya ezintweni ezithuthukile zezimboni — siletha ubuhle be-silica obuhambisana nezindinganiso eziqine kakhulu ze-pharmacopoeia nezimboni zomhlaba.