Izinganiso ze-Silica Yomuthi Wokuxubha wase-Korea vs. i-QB/T 2346 yase-China — Lokho Wonke Umthengi Okufanele Akwazi

Kwadalwa ngo 08.24

Uma wake wathola i-precipitated silica yokuxubha amazinyo evela e-China futhi wazama ukuyithengisa e-South Korea, cishe uhlangane nodonga olufanayo: ithimba lokuqinisekisa ikhwalithi yase-Korea libuyisela i-Certificate of Analysis yakho linamamaki abomvu. Umkhiqizo uhlangabezana nezinga le-China QB/T 2346. Kungase ngisho nokuhlangabezana ne-USP-NF. Kodwa ikhasimende lase-Korea lifuna izinguquko — i-pH eqinile, i-chloride ephansi, i-sulfate ephansi, ubumsulwa obuphezulu, kanye nesimo sokomisa esihlukile.

Lokhu akusiyona inkinga yamaphepha. Kuwugebe lezindinganiso elingabambezela ukuthunyelwa, libangele ukwenqatshwa, futhi linciphise inzuzo ngokuthula. Nansi ngqo into ehlukile, ukuthi kungani ibalulekile, nokuthi ungavalwa kanjani leli gebe.

Ukuqhathanisa umehluko wezinga le-silica yomuthi wokuxubha amazinyo phakathi kwe-China QB/T 2346 ne-Korean Food Additives Code

Izimiso Ezimbili Zokulawula, Isithako Esisodwa

I-China ihlukanisa i-silica yezinga lezokuxubha ngaphansi kwe-QB/T 2346-2015 ("Imikhiqizo Yokunakekela Umlomo Nokuhlanza — I-Silicon Dioxide Yezokuxubha"), okuyindinganiso enconyiwe yezimboni ezincane ekhishwe uMnyango Wezobuchwepheshe Nolwazi. Kuyindinganiso yezimboni eqondene nomkhiqizo eyakhelwe ukusebenza kwezokuxubha: ukugqwayiza, ukujiya, ukucaca, ubumhlophe, kanye nokuhlanzeka okuyisisekelo.

I-South Korea ithatha indlela ehlukile. I-silica yezokuxubha ibuyekezwa ngaphansi kwe-Korean Food Additives Code (식품첨가물공전) eshicilelwe uMnyango Wezokuphepha Kokudla Nezidakamizwa (MFDS). Ngenxa yokuthi lesi sithako sithathwa njengesithako sokudla, ukugcizelela kushintshela ekuhlanzekeni, izinsimbi ezisindayo, usawoti oncibilikayo, kanye nemikhawulo yezinsalela — indlela efanayo esetshenziswa kunoma yini engena emlonyeni.

Empeleni, abathengi base-Korea bavame ukuya phambili futhi bafake izidingo ze-USP-NF monograph ngaphezu kwe-Food Additives Code. Umphumela wukucaciswa okuhlanganisiwe okuqinile kunalezo zindinganiso zombili zodwa.

Eceleni: Izimfuneko Ezibalulekile Ngempela

Ipharamitha	I-China QB/T 2346-2015	Ikhodi Yokudla YaseKorea	Umthengi waseKorea (i-USP-NF overlay)
Ubumsulwa be-SiO₂	≥96–98% (ngokwezinga)	≥94% (okuncibilikisiwe)	≥99.0%
Ukulahlekelwa kokomiswa	≤10% ku-105°C	≤7% ku-105°C, 2 h	≤5.0% ku-145°C, 4 h
Ukulahlekelwa kokusha	≤8.5% ku-1000°C	≤8.5% ku-900–1000°C, ihora eli-1	≤8.5% ku-1000°C, ihora eli-1
pH (5% slurry)	5.5–8.5 (ngokwezinga)	Akucacisiwe	6.0–8.0
I-Chloride	≤0.3%	Ilawulwa ngosawoti abancibilikayo	<0.1%
I-Sulfate	Akubekwa ngokwehlukana (usawoti wonke ≤2.0%)	Ilawulwa ngosawoti oncibilikayo	<0.5%
Umthofu (Pb)	≤15 mg/kg	≤5.0 ppm	≤5 ppm
I-arsenic (As)	≤3 mg/kg	≤4.0 ppm	≤3 ppm
I-Mercury (Hg)	Akucacisiwe	≤1.0 ppm	≤1 ppm
Usawoti oncibilikayo onama-ion	Usawoti wonke ≤2.0%	Umkhawulo wokuqhuba (olingana no-≤250 mg Na₂SO₃/250 mL)	Imikhawulo ye-chloride ne-sulfate

Ukuhlolwa kwekhwalithi yelabhorethri ye-precipitated silica, ukuhlola ubumsulwa nezimo zokomisa zomuthi wokuxubha amazinyo

Lapho Igebe Lizwa Ubuhlungu Kakhulu

1. Ubumsulwa: 98% vs. 99%

I-QB/T 2346 ibeka umkhawulo we-SiO₂ ku-96–98% ngokuya ngezinga. Umthengi waseKorea ufuna u-99.0% ngesisekelo esivuthiwe — okuwumkhawulo we-USP-NF. Lelo phuzu elilodwa lephesenti liphoqa ukuwashwa okuqinile, ukulawulwa kwesikhathi eside, nokuqapha okuqinile kwenqubo. I-precipitated silica yezinga lokuthengisa ivamise ukufinyelela ku-97–98%; ukufinyelela ku-99% ngokungaguquki kudinga umugqa wokukhiqiza oklanyelwe ubumsulwa bezinga le-pharma.

2. Ukulahlekelwa Kokomisa: 105°C vs. 145°C

Lena imininingwane evame ukubamba abathengisi abaningi bengalindele. I-QB/T 2346 ikala izinto ezihwamukayo ku-105°C ngomkhawulo we-10%. Indlela yaseKorea/USP yomisa ku-145°C amahora angu-4 ngomkhawulo we-5.0%. Izinga lokushisa eliphezulu likhipha umswakama oboshiwe nama-hydroxyl groups angaphezulu aphila ku-105°C. Into edlula ku-105°C ngomswakama ongu-5% ingahluleka kalula ku-145°C ngo-6–7%. Umthelela wokukhiqiza ungokoqobo: udinga umswakama osele ophansi kusuka kumshini wokomisa, hhayi nje ukuhlolwa okuhlukile elebhu yokulawula ikhwalithi.

3. I-Chloride: 0.3% vs. 0.1%

I-sodium chloride ingumkhiqizo ongemuva wokusabela kokuncibilika phakathi kwe-sodium silicate ne-sulfuric acid. I-QB/T 2346 ivumela kuze kufike ku-0.3%; abathengi baseKorea bafuna ngaphansi kuka-0.1%. Lokho kudinga imijikelezo eyengeziwe yokugeza noma ukuhlunga okuthuthukisiwe — kokubili lokhu kwengeza izindleko kodwa futhi kunciphisa ubungozi bokugqwala, kuthuthukise ukuhambisana ne-fluoride, futhi kuqede ukunambitheka okungafanele kumuthi wokuxubha wokugcina.

4. I-Sulfate: Ayilawulwa Ngokwehlukana vs. <0.5%

Izinga laseShayina lilawula usawoti ophelele (Na₂SO₄ + NaCl) ukuthi ungabi ngaphezu kuka-2.0% kodwa alikhawulelisi i-sulfate ngokuhlukile. Abathengi baseKorea babeka i-sulfate ngaphansi kuka-0.5% (njenge-Na₂SO₄). I-sulfate eseleyo ithinta ukunambitheka, ingase ihlangane nezinhlelo ze-fluoride, futhi ibangela ukugqwala kwamashubhu ngesikhathi sokuphila komkhiqizo. Kumazinyo acwengekile (transparent gel) — isigaba lapho izinhlobo zaseKorea zihamba phambili khona — ukulawula i-sulfate akuxoxiswana ngakho.

5. Ifasitelana le-pH: 5.5–8.5 vs. 6.0–8.0

Ifasitelana elincane elingu-6.0–8.0 livikela ukuqina kwe-fluoride (ikakhulukazi izinhlelo ze-sodium monofluorophosphate) futhi linciphisa amathuba okucasula izinzwa zomlomo kubathengi abanezinsini ezibucayi. Kuzwakala sengathi umehluko omncane, kodwa ukushaya ibhentshi elingu-6.0–8.0 njalo nje kudinga ukulawula okuqinile kwe-pH ngesikhathi sokuncibilika nokuqedela.

6. Izinsimbi Ezisindayo: Umthofu ne-Mercury

Ikhodi Yokungeza Ukudla YaseKorea ibeka umkhawulo we-lead ku-5 ppm — okuqinile ngokuphindwe kathathu kune-QB/T 2346 engu-15 mg/kg — futhi ingeza umkhawulo we-mercury ongu-1 ppm okungacaciswa yizinga laseShayina. Kubathumeli bangaphandle, lokhu kusho ukuthi ukukhethwa kwezinto zokusetshenziswa (ikhwalithi ye-sodium silicate, izinga le-sulfuric acid) kanye nemigqa yokukhiqiza ekhethekile kubalulekile njengokuhlolwa komkhiqizo ophelile.

Lokhu Kusho Ukuthini Kubathumeli

Uma uthola i-toothpaste silica yemakethe yaseKorea, i-COA ebhekisela kuphela ku-QB/T 2346 ayanele. Udinga izinto ezintathu kumthengisi wakho:

1. I-COA enezinga elikabili: Isitifiketi kufanele sibhale kokubili i-USP-NF ne-QB/T 2346 njengezindinganiso zokubhekisela, nezindlela zokuhlola nezimo ezishiwo ngokucacile (145°C/amahora ama-4 we-LOD, 1000°C/ihora eli-1 le-LOI).

2. Imininingwane ye-chloride ne-sulfate yebhantshi ngalinye: Hhayi nje "usawoti wonke ≤2%." Funela imiphumela ye-chloride ne-sulfate ngayinye ngebhantshi ngalinye.

3. Iphaneli lensimbi esindayo ehlanganisa i-mercury: I-Pb, i-As, ne-Hg zihlolwa ngebhaji noma ngefrikhwensi eqinisekisiwe, ngemikhawulo yokutholwa ephansi ngokwanele ukufakazela ukuthobela.

Umthengi obuyekeza i-Certificate of Analysis ye-silica yomuthi wokuxubha amazinyo ngokuqhathanisa namazinga ase-Korea nawase-USP

Umugqa Wokugcina

Igebe phakathi kwamazinga e-silica yamazinyo aseShayina naseKorea alikwazi ukuvalwa kalula — kodwa lihlukanisa abahlinzeki abakwazi ukufunda isimiso kubahlanganisi abakwazi ukuklama ngokwaso. Ubumsulwa obungu-99%, isimo sokomisa esingu-145°C, i-chloride engu-0.1%, nemikhawulo yomthofu engu-5 ppm kuyatholakala, kodwa kudinga ukulawulwa kwenqubo, ukusebenza kahle kokugeza, nokuyala kwezinto ezingavuthiwe abakhiqizi abajwayelekile abangatshali kukho.

Ngaphambi kwe-oda lakho elilandelayo laseKorea, buza umhlinzeki wakho umbuzo owodwa: "Ungathumela ibhaji lapho yonke imininingwane ku-COA ihlangabezana ne-USP-NF ne-QB/T 2346 ngasikhathi sinye?" Uma enganqikazi, usunayo impendulo yakho.

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