I-USP-NF vs. QB/T 2346 — Inselele Yezinga Eliphindwe Kabili Yabathengisi Be-Silica Yamazinyo

Kwadalwa ngo Ngokwamukisa

Bonke abathengisi be-silica abake basebenza nabathengi baseKorea, baseJapane, baseYurophu, noma baseMelika bayayazi le nkathi. I-COA yakho yasekhaya — ehambisana ngokugcwele ne-QB/T 2346-2015 — ifika etafuleni lekhasimende, impendulo ibuye ithi: "Sicela unikeze noma idatha yokuhambisana ne-USP-NF." Noma kubi kakhulu: "I-chloride yakho ingu-0.15%, umkhawulo wethu ngu-0.1%. Sicela uyilungise."

Kungazelelwe awuthengisi nje i-precipitated silica. Uzulazula kumibhalo emibili enezindlela ezahlukene zokuhlola, imikhawulo ehlukene, nezinhloso ezahlukene — futhi ikhasimende lakho lilindele kokubili ku-Certificate of Analysis eyodwa. Lesi sihloko sihlukanisa wonke umehluko obalulekile phakathi kwe-USP-NF Silicon Dioxide ne-QB/T 2346 yaseShayina, futhi sichaza indlela yokwakha nokubhala umkhiqizo ohambisana nakho kokubili.

ukuqhathanisa amazinga amabili i-USP-NF ne-QB/T 2346 kubathumeli be-precipitated silica

Amazinga Amabili, Izinhloso Ezimbili

I-QB/T 2346-2015 iyindinganiso yezimboni ehlongozwayo yaseShayina ye-silica yezinga lokuxubha amazinyo. Igxile ekusebenzeni: ichaza imikhiqizo emithathu (ukuxubha, okuphelele, ukujiya) futhi ibeka izindinganiso mayelana nobukhulu bezinhlayiyana, ubumhlophe, ukumunca uwoyela, ukumunca amanzi, ukuminyana okubonakalayo, kanye nenani lokuxubha — izakhi ezinquma indlela i-silica eziphatha ngayo ekwakhiweni kwezinto zokuxubha amazinyo.

I-USP-NF Silicon Dioxide iyincwadi yemithi ye-pharmacopeia. Igxile ekuphepheni nasekuhlanzekeni: ichaza i-silica njengesithasiselo, ibeka izinga lokuhlanzeka elingu-99%, ibeka umkhawulo ku-chloride, sulfate, arsenic, nezinsimbi ezisindayo, futhi icacisa izimo zokuhlola eziqondile (145°C amahora angu-4, 1000°C okungenani ihora elingu-1). Ayinaki i-RDA noma ukumunca uwoyela ngoba lezo yizinto eziguquguqukayo ekwakhiweni, hhayi izilinganiso zokuphepha.

Lapho umthengi waseKorea ebuza kokubili, ufuna umkhiqizo okulungele ukwakhiwa futhi ohlanzekile njengesithasiselo ngesikhathi esisodwa.

Ukuqhathanisa Ipharamitha Ngapharamitha

Ipharamitha	I-Silicon Dioxide ye-USP-NF	QB/T 2346-2015	Umgomo Wokuthobela Okubili
Okuqukethwe kwe-SiO₂	≥99.0% (isisekelo esivuthiwe)	≥96–98% (ngokwezinga)	≥99.0%
Ukulahlekelwa kokomisa	≤5.0% ku-145°C, amahora angu-4	≤10% ku-105°C	≤5.0% ku-145°C, amahora angu-4
Ukulahlekelwa ukusha	≤8.5% ku-1000°C, ≥1 h	≤8.5% ku-1000°C	≤8.5% ku-1000°C, 1 h
i-pH	4–8 (i-slurry engu-1:20)	5.5–8.5 (i-slurry engu-5%, ngokwezinga)	6.0–8.0 (i-slurry engu-5%)
I-Chloride	≤0.1%	≤0.3%	<0.1%
I-Sulfate	≤0.5%	Akubekwanga ngokwehlukana	<0.5%
Arsenic	≤3 ppm	≤3 mg/kg	≤3 ppm
Izinsimbi ezisindayo (njenge-Pb)	≤30 ppm (Indlela I)	≤15 mg/kg	≤15 ppm (i-QB/T iqinile)
Umthofu (Pb)	Akubekwanga ngokwehlukana ku-USP yakudala	≤15 mg/kg	≤5 ppm (ukugqagqana kwaseKorea)
I-Mercury (Hg)	Akucacisiwe	Akucacisiwe	≤1 ppm (ukugqitshwa kwe-Korea)
Usawoti ophelele	Akucacisiwe	≤2.0%	≤2.0% (kanye nemikhawulo ye-Cl/SO₄)
Iron (Fe)	Not specified	≤350–500 mg/kg	≤350 mg/kg
Ubumhlophe	Akucacisiwe	≥93–96% (ngokwezinga)	≥96%
Ukudlula kusihluli se-325-mesh	Akucacisiwe	≥98%	≥98%

ukuhlolwa kwelabhorethri yokulawula ikhwalithi yobumsulwa be-silica, ukuhlanza, ukuqhuba kagesi, nezinsimbi ezisindayo

Izinkinga Ezinzima Kakhulu Ezinhlanu (nokuthi Zixazululwa Kanjani)

Inkinga 1: Ukuhlolwa Kokulahlekelwa Ukoma Ku-145°C

Lena yiphuzu elivame kakhulu ukwehluleka. I-QB/T 2346 ihlola ku-105°C; i-USP-NF ihlola ku-145°C amahora angu-4. Umehluko wama-degree angu-40 awukhiphi nje umswakama ovulekile kodwa futhi ukhipha amanzi aboshwe ngokukhululeka kanye namanye amaqembu e-silanol angaphezulu. I-silica ebonisa i-LOD engu-5% ku-105°C ingabonisa u-6.5–7.5% ku-145°C.

Isixazululo: Lungisa isinyathelo sokomisa nokugaya ukuze uthole umswakama ophumayo ophansi (okuhlosiwe 4–5% ku-145°C). Lokhu kungadinga izinga lokushisa eliphezulu lomisi, isikhathi eside sokuhlala, noma isigaba sokomisa ngokushesha. Qinisekisa ngokuhlolwa kwe-USP 145°C/4 h elabhorethri yakho ngaphambi kokuthumela ngakunye.

Inkinga 2: Ukusuka ku-98% kuya ku-99% SiO₂

Igebe phakathi kuka-98% no-99% cishe lonke usawoti we-sodium sulfate nosawoti we-sodium chloride osele ekuphenduleni kokuncibilika. I-QB/T 2346 ivumela usawoti ophelele ufinyelele ku-2.0%; I-USP-NF yokulinganiselwa kwe-chloride ne-sulfate iphushela usawoti ophelele ngaphansi kuka-~0.7%.

Isixazululo: Engeza izigaba zokugeza ezihamba ngokuphambene noma thuthukisa ukugeza kwe-filter-cake. Sebenzisa amanzi ahlanzekile (deionized) ukugeza kokugcina. Qapha ukukhanya kukagesi (conductivity) kokuhluzayo — uma kusondela ekukhanyeni kwamanzi okungenayo, usawoti ususwe ngempumelelo.

Inkinga 3: I-Chloride ngaphansi kuka-<0.1%

I-QB/T 2346 ivumela i-chloride engu-0.3%; abathengi base-USP-NF nabaseKorea bafuna <0.1%. I-chloride ivela ku-NaCl osele ekhekheni. Ukuthuthukiswa kokuwasha okufanayo okukhuphula ubumsulwa kuzokwehlisa i-chloride, kodwa kufanele uqinisekise ngoba i-chloride ne-sulfate zigezwa ngezinga elihlukile.

Isixazululo: Hlola i-chloride esigabeni ngasinye sokuwasha. Uma i-chloride ihlala ngaphezu kuka-0.1%, cabanga ngokuwasha kabusha (hlanganisa ikhekhe emanzini e-DI bese uhlunga futhi) kunokuba umane welule ukugezwa kokugcina.

Inkinga 4: Ifasitela le-pH 6.0–8.0

I-USP-NF ivumela i-pH 4–8; i-QB/T 2346 ivumela u-5.5–8.5 ngokuya ngezinga. Abathengi baseKorea bayanciphisa bafike ku-6.0–8.0. I-pH ye-silica ejiyile inqunywa ukulinganisela kwe-asidi/isiqeshana esisele kanye ne-chemistry yobuso. Ukugeza ngokweqile ngamanzi aphethwe nge-asidi kungayehlela i-pH ibe ngaphansi kuka-6; ukugeza okunganele kuyishiya ngaphezu kuka-8.

Isixazululo: Lawula i-pH yamanzi okugeza okokugcina futhi uqaphe i-pH yekhekhe ngemva kokomiswa. Uma i-pH yehla ibe phansi, kungadingeka ukulungiswa okuncane okune-alkaline ngesikhathi sokugeza kokugcina — kodwa lokhu akumelwe kubuyisele usawoti we-sodium.

Inkinga 5: Amadokhumenti e-Mercury ne-Lead

I-USP-NF (izinguqulo ezindala) ne-QB/T 2346 azidingi ukuhlolwa kwe-mercury, kodwa i-Korean Food Additives Code ibeka umkhawulo we-Hg ku-1 ppm. I-Lead ingu-15 mg/kg ngaphansi kwe-QB/T 2346 kodwa ingu-5 ppm ngaphansi kwezimfuneko zase-Korea.

Isixazululo: Engeza i-Hg ne-Pb (kanye ne-As) ohlwini lwakho olujwayelekile lwezinsimbi ezisindayo usebenzisa i-ICP-MS noma i-atomic absorption. Thola i-sodium silicate kubaphakeli abanezinsimbi ezisindayo eziphansi. Uma wabelana ngemigqa yokukhiqiza nezigaba zezimboni, sebenzisa izinqubo zokuhlanza nokushintsha nokuqinisekisa ukuthi umugqa ukhululekile.

Indlela Yokukhipha i-COA Enamazinga Amabili

I-COA ehlangabezana nabathengi base-Korea, eYurophu, noma baseMelika kufanele ifake lezi zinto ezilandelayo:

1. Igama lomkhiqizo: "Izithako Zokudla I-Silicon Dioxide (I-Precipitated Silica) Yomuthi Wamazinyo" — lolu limi lukhombisa izinga lezithako zokudla

2. Izindinganiso ezisetshenziswayo: Faka kokubili "USP-NF" kanye "QB/T 2346-2015" (futhi ngokuzithandela ne-Korean Food Additives Code)

3. Izindlela zokuhlola ezinezimo: "Ukulahlekelwa kokoma, 145°C, amahora angu-4" — hhayi nje "Ukulahlekelwa kokoma ≤5%"

4. Imiphumela ngayinye ye-chloride ne-sulfate — hhayi kuphela usawoti wonke

5. Iphaneli yensimbi esindayo: Pb, As, ne-Hg ngamanani angempela nemikhawulo yokutholwa

6. Imiphumela ye-microbiological: Isibalo esiphelele se-aerobic, isikhunta nomgomo, kanye nokungabikho kwamagciwane athile (E. coli, P. aeruginosa, S. aureus)

7. Idatha yokusebenza: I-RDA, ukumuncwa kukawoyela, ukumuncwa kwamanzi, ubumhlophe, nobukhulu obubonakalayo begreyidi ethile

isitifiketi esisezingeni eliphindwe kabili se-Certificate of Analysis (COA) sokugunyazwa kokuthunyelwa kwe-silica yamazinyo

Iseluleko Sokugcina Sabathumeli

Ukuthobela izindinganiso ezimbili akusiyona inkinga ye-QC — kuyifilosofi yokukhiqiza. Uma umugqa wakho wenzelwe ukukhiqiza impahla ye-QB/T 2346, ngeke uhlale ufinyelela imikhawulo ye-USP-NF ngokuhlola kanzima. Udinga ukwakha ubumsulwa enqubweni: izinto zokusetshenziswa ezihlanzekile, ukugeza okwengeziwe, ukomisa okuqinile, nokuqapha njalo izinsimbi ezisindayo.

Abahlinzeki abanqoba ama-oda ase-Korea nawomhlaba yilabo okuthi ama-COA abo asevele ebonisa izinombolo — hhayi labo abathembisa ukuthi "bazolungisa i-oda lakho."

Contact

Leave your information and we will contact you.