USP, EP, GMP pharmaceutical grade Sodium CMC
Sodium carboxymethyl cellulose (CMC) o loʻo faʻaaogaina i vailaʻau faʻapitoa e tatau ona ausia tulaga faʻapitoa e faʻamautinoa ai lona saogalemu, aoga, ma talafeagai mo le faʻaaogaina i vailaʻau. O le United States Pharmacopeia (USP), European Pharmacopoeia (EP), ma le Good Manufacturing Practice (GMP) taʻiala o loʻo tuʻuina atu ai faʻamatalaga ma manaʻoga mo CMC vasega vailaʻau. O le auala lenei e faʻaoga ai nei tulaga faʻatatau i vailaʻau-vasega CMC:
- USP (United States Pharmacopeia):
- O le USP ose fa'asalalauga fa'apitoa o tulaga fa'atauva'a e aofia ai fa'amatalaga mo vaila'au vaila'au, fa'asologa o vaila'au, ma faiga su'ega.
- USP-NF (United States Pharmacopeia-National Formulary) monographs e maua ai tulaga mo le sodium carboxymethyl cellulose, e aofia ai manaʻoga mo le mama, faʻamaonia, suʻega, ma isi uiga lelei.
- Ole CMC ole vasega ole vaila'au e tatau ona tausisia fa'amatalaga o lo'o fa'amatala atu ile monokalafi a le USP e fa'amautinoa ai lona lelei, mama, ma le talafeagai mo le fa'aogaina o vaila'au.
- EP (European Pharmacopoeia):
- O le EP o se faʻasalalauga tutusa o tulaga faʻapitoa mo vailaʻau ma mea faʻaoga, e iloa i Europa ma le tele o isi atunuʻu.
- O le EP monograph mo le sodium carboxymethyl cellulose o loʻo faʻamaoti mai ai manaʻoga mo lona faʻamatalaga, mama, mea faʻapitoa faʻapitoa, ma uiga microbiological.
- CMC tulaga tau vaila'au fa'amoemoe e fa'aoga i Europa po'o atunu'u o lo'o fa'aaogaina tulaga fa'ata'atia a le EP e tatau ona ausia fa'amatalaga o lo'o fa'amatala atu i le monokalafi a le EP.
- GMP (Fa'ata'ita'iga Lelei Gaosia):
- O taʻiala a le GMP e tuʻuina atu tulaga ma manaʻoga mo le gaosiga, faʻataʻitaʻiga, ma le faʻatonutonuina lelei o oloa vailaʻau.
- E tatau i kamupani gaosi oloa CMC ona tausisi i tulafono faatonutonu a le GMP ina ia mautinoa le gaosiga faifaipea o oloa maualuga ma saogalemu.
- O mana'oga a le GMP e aofia ai vaega eseese o le gaosiga, e aofia ai le fa'atulagaina o fale, a'oa'oga a tagata faigaluega, fa'amaumauga, fa'amaoniga o fa'agasologa, ma faiga fa'atonutonu lelei.
Ole vaila'au-grade sodium carboxymethyl cellulose e tatau ona fa'amalieina le mama, fa'asinomaga, ma tulaga lelei mana'omia o lo'o fa'amatala atu ile tala fa'atatau ole vaila'au (USP po'o le EP) ma usita'ia tulafono a le GMP e fa'amautinoa ai lona talafeagai mo le fa'aogaina i vaila'au. O le au gaosi oloa ole vaila'au CMC e nafa ma le tausisia o tulaga maualuga o le lelei ma faʻamautinoa le tausisia o tulafono faʻatonutonu e puipuia ai le soifua maloloina ma le saogalemu o tagata maʻi.
Taimi meli: Mati-07-2024