I-carboxeymethylcelcelcelse Ipropathi yakhe yezinto ezininzi ezininzi zenza ukuba ixabiseke njengearhente yokuthambisa, i-stabilizer, i-mulsifier, nangaphezulu. I-United States yokutya kunye nolawulo lweziyobisi (i-FDA) idlala indima ebalulekileyo ekulawuleni ukhuseleko kunye nokusetyenziswa kweendawo ezixineneyo, ukuqinisekisa ukuba zihlangabezana nemigangatho engqongqo ngaphambi kokuba zivunywe kwiimveliso zabathengi.
Ukuqonda i-carboxymethylcelose (cmc)
I-carboxeymethylcelcelcelose, ihlala ifinyezwe njenge-CMC, kukuphazamiseka kwesellulose. I-SellUlose yeyona nto ibalulekileyo emhlabeni kwaye ifumaneka kwiindonga zeseli zezityalo, zibonelela ngenkxaso yesakhiwo. I-CMC isuselwa kwiselpulose ngenkqubo yokuhlengahlengiswa kwekhemikhali ebandakanya ukuqalisa amaqela e-carboxymethyl kwi-selsulose i-selbone. Olu tshintsho lubonisa iipropathi ezininzi eziluncedo kwi-CMC, kubandakanya ukubenzela amanzi, i-viscosity, kunye nozinzo.
Iipropathi zebhokisi yebhokisi ye-carboxymethylcelcelcelcelcelcelcelcelcelose:
I-Solubaty yaManzi: I-CMC inyibilikisa emanzini, yenze isisombululo esicacileyo, se-viscous. Le propati yenza ukuba iluncedo kwizicelo ezahlukeneyo apho iarhente yokuthambisa okanye yokuzinzisa imfuneko.
I-VICOSITY: I-CMC ibonisa indlela yokuziphatha ye-pseudoplastic, intsingiselo yokufakwa kwayo incipha phantsi koxinzelelo lwe-Shear kwaye yonyuka kwakhona xa uxinzelelo lususiwe. Le ndawo ivumela ukusetyenziswa ngokulula kwiinkqubo ezinjengempompo, ukutshiza, okanye ukuphuma.
Uzinzo: I-CMC idlulisela uzinzo kwizinto zokuzimisela kunye nokumiswa, ukuthintela izithako ezivela kwisahluli okanye ukulungisa ixesha elingaphezulu. Oku kuzinza kubaluleke kakhulu kwiimveliso ezinjengokucofa kwesaladi, i-cosmetics, kunye nokumiswa ngamayeza.
Ukwenza ifilimu: I-CMC inokwenza iifilimu ezinqabileyo, eziguquguqukayo xa yomile, iyenza iluncedo kwizicelo ezifana nokunxiba kweetafile okanye kwimveliso yeefilimu zezinto zokupakisha.
Ukusetyenziswa kwe-carboxymethylcelcelcelcelcelose
I-CMC ifumana ukusetyenziswa ngokubanzi kwamashishini ahlukeneyo ngenxa yezinto zayo eziguquguqukayo. Ezinye iindlela eziqhelekileyo zibandakanya:
Umzi-mveliso wokutya: i-CMC isetyenziswa njenge-gickener, i-stabilizer, kunye ne-binder kuluhlu olubanzi lweemveliso zokutya, kubandakanya neesosi, ukunxiba, i-ice cream, kunye neziselo. Inceda ukuphucula ukuthungwa, umlomo kunye nokuzinza kweshesi.
Amayeza: Kwi-Hommaceuticals, i-CMC isetyenziswa njenge-binder kwifom yetafile, i-thi churener kwiminquba, kunye nokuzinzisa kwi-emulsions. Iqinisekisa ukuhanjiswa kweziyobisi kunye nokuphucula ukuthotyelwa koguli.
I-cosmetics kunye neemveliso zononophelo zobuqu: i-CMC iqeshwa kwi-cosmetics kunye neemveliso zononophelo zobuqu ezifana ne-ores, iikhrim, i-shamps, kunye ne-toothste, kunye nokuzibulala. Inceda ukugcina inguqulelo yemveliso kwaye iphucule intsebenzo.
Izicelo zeMizi-mveliso: I-CMC isetyenziswa kwiinkqubo ezahlukeneyo zemizi-mveliso njengendawo yokugcina amanzi, iarhente yokugcina amanzi, kunye ne-Rheoology kwiimveliso ezinje ngezicotho, iipeyinti, kunye nokuntywila.
Inkqubo yokuvunywa kweFDA
E-United States, i-FDA ilawula ukusetyenziswa kwezinto zokongezwa kokutya, kubandakanya izinto ezinjenge-CMC, phantsi kwe-CMC, phantsi koMthetho wokutya, ichiza, kunye nezongezo zeCosmetic (I-FD & C) kunye nolungiso oluphambili lwe-FDA kukuqinisekisa ukuba izinto Yongezwe kukutya kukhuselekile ekusetyenzisweni kwaye kusebenzele injongo eluncedo.
Inkqubo yokuvunywa kwe-FDA yezicelo zokutya eziqhele ukubandakanya la manyathelo alandelayo:
UVAVANYO LWEZOKHUSELEKILEYO: Umenzi okanye umthengisi wesongezo sokutya unoxanduva lokuqhuba izifundo zokhuseleko ukubonisa ukuba i-thes ikhuselekile ukusetyenziswa kwayo. Ezi zifundo ziquka uvavanyo lwetyhefu, izifundo kwiMetabolism, kunye ne-Altragejinity enokubakho.
Ukungeniswa kwezikhalazo zokutya: Umvelisi ungenisa isikhalazo songezelelo (i-FAP) kwi-FDA, ukubonelela ngolwazi oluneenkcukacha malunga nesazisi, ukwakhiwa, inkqubo yokwenziwa, ukusetyenziswa kwedatha, kunye nedatha ejolise kuyo. Uxwebhu lwezikhalazo kufuneka lubandakanye iimfuno ezinelebheli ezichaziweyo.
Uphononongo lwe-FDA: I-FDA ivavanya idatha yoKhuseleko ebonelelwe kwi-fap ukufumanisa ukuba ngaba i-Aptive ikhuselekile ekusetyenzisweni kwayo phantsi kwemiqathango echazwe ngummeli. Olu hlaziyo lubandakanya uvavanyo lwengozi olunokubakho kwimpilo yabantu, kubandakanya amanqanaba abonakalisiweyo kunye naziphi na iziphumo ezibi.
Ukupapashwa kommiselo ocetywayo: Ukuba i-FDA igqiba ukuba ikhuselekile, ipapasha ummiselo ocetywayo kwirejista ye-Federal, echaza iimeko ezinokusetyenziswa phantsi kwazo ukutya. Olu papasho luvumela izimvo zoluntu kunye negalelo elivela kubathathi-nxaxheba.
Ukulawula: Emva kokuthathela ingqalelo amagqabantshintshi oluntu kunye nedatha eyongezelelweyo, imicimbi ye-FDA imvume yokugqibela nokuba ivume okanye ilahle ukusetyenziswa kwesongezo. Ukuba ivunyiwe, ulawulo lokugqibela lumisela iimeko ezivumelekileyo zokusetyenziswa, kubandakanya naziphi na izinto, iinkcukacha, okanye iilebheli ezifuneka.
I-carboxymethylcelcelcelse kunye ne-FDA imvume
I-carboxeymethylcelcelcelcelse inembali ende yokusetyenziswa kwishishini lokutya kunye namanye amacandelo, kwaye ibonwa njengendawo ekhuselekileyo (i-GRA) isetyenziswa ngokuhambelana nezenzo ezifanelekileyo zemveliso. I-FDA ikhuphe imimiselo ethile nezikhokelo ezinikezela ukusetyenziswa kwe-CMC ekutyeni nakwimveliso yamachiza.
Ukulawulwa kwe-FDA ye-carboxymethylcelose:
Imeko yoyilo yokutya: I-carboxymethylcelcelcelcelcelose idweliswe njengezinto ezivunyiweyo zokutya kwiSihloko 21 seKhowudi yeMicimbi yeMicimbi yeFederal (CFR) phantsi kwecandelo 172.Code 8672, kunye nemigaqo ethile echazwe kudidi oluthile lokutya. Le migaqo icacisa ukuba amanqanaba aphezulu e-CMC kwiimveliso ezahlukeneyo zokutya kunye nakuphi na ezinye iimfuno ezifanelekileyo.
Ukusetyenziswa kwamayeza: Kwi-Hermaceuticals, i-CMC isetyenziswa njengesithako esingasebenziyo kwiziko lamachiza, kwaye ukusetyenziswa kwayo kulawulwa phantsi kweZiko le-FDA kuvavanyo lweziyobisi nophando (CDER). Abavelisi kufuneka baqinisekise ukuba i-CMC ihlangabezana neenkcazo ezichazwe kwi-United States Pharmacopeia (i-USP) okanye enye into efanelekileyo.
Iimfuneko zelebheli: iimveliso eziqukethe i-CMC njengesithako kufuneka sithobele imigaqo-nkqubo ye-FDA malunga nelebheli, kubandakanya uluhlu oluchanekileyo lwefayile kunye nayiphi na ilebheli efunekayo.
I-carboxeymethylcelcelcelse (cmc) isetyenziswe ngokubanzi kwizicelo ezahlukeneyo ekutyeni, amayeza, entsebenzo kunye nemizi mveliso. Iipropathi zayo ezizodwa zenza ukuba kube yinto ebaluleke kakhulu njenge-thi checker, i-sticker, i-mulsifier, kunye ne-binder kwiimveliso ezahlukeneyo. I-FDA idlala indima ebalulekileyo ekulawuleni ukhuseleko kunye nokusetyenziswa kwe-CMC kunye nezinye izongezelelo zokutya, ukuqinisekisa ukuba ziyayifezekisile imigangatho yokhuseleko engqongqo ngaphambi kokuba zivunywe kwiimveliso zabathengi. I-CMC idweliswe njengophawu lokutya okuphelelwe yi-FDA, kwaye ukusetyenziswa kwayo kulawulwa yimigaqo kunye nezikhokelo ezichazwe kwiSihloko 21 seKhowudi yeMigaqo yeMicimbi yeFederal. Abavelisi kunye nabathengisi beemveliso eziqukethwe i-CMC kufuneka balandele ngqo le migaqo, kubandakanya uvavanyo loKhuseleko, iimfuno zokuthengisa, kunye neemeko ezichaziweyo, ukuqinisekisa ukhuseleko kunye nomgangatho weemveliso zabo.
IXESHA LOKUQALA: UMar-22-2024