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I-Croscarmellose Sodium Superdisintegrant yeeThebhulethi zamayeza | Ukudumba okukhawulezayo, iNqanaba lokusetyenziswa eliphantsi yi-0.5-5% | I-USP/EP/JP Iyahambelana

I-Croscarmellose Sodium yethu yi-superdisintegrant ecocekileyo kakhulu eyenzelwe iifom zomthamo oqinileyo womlomo kuquka iipilisi, iikhaphu, kunye neegranules. Yi-sodium carboxymethylcellulose edibeneyo ngaphakathi enganyibiliki emanzini kodwa ikhula ngokukhawuleza ukuya kuthi ga kwi-4-8 ivolumu yayo yokuqala xa idibana ne-aqueous media.Esi sakhiwo sikhethekileyo sinee-fiber sinika amandla amahle okucoca amanzi kunye nokusebenza kakuhle kwe-capillary, nto leyo ekhokelela ekuqhekekeni okuphezulu kwethebhulethi kunye nokuphuculwa kokunyibilika kwamayeza.. Ihambelana ne-USP-NF, EP, JP, kunye ne-ChP pharmacopoeias kunye ne-CDE registration F20209990136Inqanaba eliqhelekileyo lokusetyenziswa: 0.5-5.0% w/w (2% yoxinzelelo oluthe ngqo, 3% yomxube omanzi)Ifanelekile ukucinezelwa ngokuthe ngqo, ukugalelwa kwe-granulation emanzi (ngaphakathi okanye ngaphandle kwe-granular), ukuxinana kwe-roller, kunye ne-capsule formulations

    I-Croscarmellose Sodium yeKlasi yaMayeza (i-CCS)

    Isishwankathelo seMveliso

    ICroscarmellose Sodium yi-sodium carboxymethylcellulose edityaniswe ngaphakathi, eyenzelwe ngokukodwa ukusetyenziswa njenge-superdisintegrant kwi-pharmaceutical formulationsNgokungafaniyo nezinto eziqhekekayo eziqhelekileyo, inika iipropati eziqhekekayo ezibalaseleyo xa zinomlinganiselo ophantsi, iqinisekisa ukuqhekeka ngokukhawuleza kweepilisi kunye nokuphuculwa kokunyibilika kwamayeza ukuze kubekho ukufumaneka okuphuculweyo kwezinto eziphilayo..

    Ubume beMveliso:

    • Igama leKhemikhali:I-Crosscarmellose Sodium

    • Inombolo ye-CAS:74811-65-7

    • Inombolo yoBhaliso lwe-CDE:F20209990136

    • Ukuthobela i-Pharmacopoeia:I-ChP, i-USP-NF, i-EP, i-JP, i-BP

    • Inombolo ye-EC:629-739-2

    • Izithethantonye:I-Carboxymethylcellulose edityanisiweyo ne-Croscarmellose, i-CCNa, i-Sodium Croscarmellose, i-E468

    Iimpawu eziphambili kunye neenzuzo

    1. Indlela Ebalaseleyo Yokuqhekeka

    • Ukuqhekeka kwezenzo ezimbini:Idibanisa isenzo se-capillary (wicking) kunye nokudumba okukhawulezayo

    • Iyanda ukuyaIphindaphindwe ka-4-8 umthamo wayo wokuqalaxa udibana namanzi

    • Ulwakhiwo olunemicu lubonelela ngezakhono ezibalaseleyo zokufunxa amanzi

    • Yenza ulwandiso loomatshini oluqhekeza ngokukhawuleza iipilisi

    2. Inqanaba lokusetyenziswa eliphantsi – Ukusebenza kakuhle okuphezulu

    • Isebenza kakuhle xa kugxilwe kumanqanaba aphantsi njenge0.5-5.0% w/w 

    • Ukusetyenziswa okuqhelekileyo: 2% yokucinezela ngokuthe ngqo, 3% yokubumbana okumanzi

    • Isisombululo esingabizi kakhulu sokuphuhlisa ifomula

    3. Ukuguquguquka kweFomu

    • Ifanelekile kuzo zonke iinkqubo zokufaka iipilisi: ucinezelo oluthe ngqo, i-granulation emanzi, ucinezelo lwe-roller

    • Kwi-granulation emanzi, ingasetyenziswa ngaphakathi kwe-granularly, extra-granularly, okanye yahlulwe phakathi kwezigaba zombini

    • Iyahambelana neefomyula ze-capsule (ukusetyenziswa kwe-10-25%)

    4. Iipropati Ezintle Zomzimba

    • Inkangeleko:Umhlophe ukuya komhlophe, umgubo ohamba ngokukhululekileyo

    • Inqanaba lokutshintsha:0.60 – 0.85

    • Umthamo Wokuhlalisa:10.0 – 30.0 ml

    • isisombululo se-pH (1%):5.0 – 7.0

    • Ilahleko xa komiswa:≤10.0%

    • Intsalela xa kutsha:14.0% – 28.0%

    • Izinto Ezinyibilikayo Ngamanzi:≤10.0%

    • Iintsimbi Ezinzima:≤10 ppm

    5. Ukuhambelana kwe-API kunye nozinzo

    • Ngabaayinazo iiperoxide– iqinisekisa uzinzo olungcono kwii-API ezibuthathaka kwi-oxidation

    • Akukho mpembelelo imbi kubunzima bethebhulethi okanye ukugungqa kwayo

    • Ukusebenza kokuqhekeka kuhlala kufana ngokuhamba kwexesha

    • Ayisiyo-GMO, ayina-allergen

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