Focus on Cellulose ethers

USP, EP, GMP pharmaceutical grade Sodium CMC

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 mai ai faʻamatalaga ma manaʻoga mo CMC vasega vailaʻau.O le auala lenei e faʻaoga ai nei tulaga faʻatatau i vailaʻau-vasega CMC:

  1. USP (United States Pharmacopeia):
    • O le USP o se 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.
  2. 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 mo le fa'aoga i Europa po'o atunu'u e fa'aaogaina tulaga fa'ata'atia a le EP e tatau ona fa'amalieina fa'amatalaga o lo'o fa'amatala atu i le monokalafi a le EP.
  3. GMP (Fa'ata'ita'iga Lelei Gaosia):
    • O taʻiala a le GMP e tuʻuina atu ai tulaga ma manaʻoga mo le gaosiga, faʻataʻitaʻiga, ma le lelei o le puleaina o vailaʻau.
    • E tatau i tagata gaosi oloa CMC ona tausisia 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
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