USP, EP, GMP urwego rwa farumasi Sodium CMC

Sodium carboxymethyl selulose (CMC) ikoreshwa mubikoresho bikoreshwa mu bya farumasi igomba kuba yujuje ubuziranenge kugira ngo umutekano wacyo, imikorere, kandi ikoreshwe mu gukoresha imiti. Ubuvuzi bwa Reta zunzubumwe za Amerika (USP), Pharmacopoeia yu Burayi (EP), hamwe nubuyobozi bwiza bwo gukora (GMP) butanga ibisobanuro nibisabwa kuri CMC yo mu rwego rwa farumasi. Dore uko aya mahame akoreshwa murwego rwa farumasi-CMC:

1. USP (Pharmacopeia yo muri Amerika):
   • USP ni igiteranyo cyuzuye cyibipimo byibiyobyabwenge bikubiyemo ibisobanuro bya farumasi, imiterere ya dosiye, nuburyo bwo gupima.
   • USP-NF (Reta zunzubumwe za Reta zunzubumwe za Amerika Pharmacopeia-National Formulary) itanga amahame ya sodium carboxymethyl selulose, harimo ibisabwa kugirango ubuziranenge, kumenyekana, gusuzuma, nibindi biranga ubuziranenge.
   • Imiti yo mu rwego rwa farumasi CMC igomba kubahiriza ibisobanuro byavuzwe muri monografi ya USP kugirango irebe ubuziranenge bwayo, ubuziranenge, kandi bukwiranye no gukoresha imiti.
2. EP (Pharmacopoeia yu Burayi):
   • EP ni igereranya risa n'ibicuruzwa bikoreshwa mu bya farumasi n'ibiyigize, bizwi mu Burayi no mu bindi bihugu byinshi.
   • EP monografi ya sodium carboxymethyl selulose yerekana ibisabwa kubiranga, ubuziranenge, imiterere ya fiziki ya chimique, nubwiza bwa mikorobi.
   • Imiti yo mu rwego rwa farumasi CMC igenewe gukoreshwa mu Burayi cyangwa mu bihugu byemera ibipimo bya EP bigomba kuba byujuje ibisobanuro byavuzwe muri monografiya ya EP.
3. GMP (Imyitozo myiza yo gukora):
   • Amabwiriza ya GMP atanga ibipimo nibisabwa mu gukora, kugerageza, no kugenzura ubuziranenge bwibicuruzwa bikoreshwa mu bya farumasi.
   • Uruganda rwa farumasi rwa CMC rugomba kubahiriza amabwiriza ya GMP kugirango habeho umusaruro uhoraho wibicuruzwa byiza kandi byiza.
   • Ibisabwa bya GMP bikubiyemo ibintu bitandukanye byinganda, harimo igishushanyo mbonera, amahugurwa y'abakozi, inyandiko, kwemeza inzira, hamwe nuburyo bwo kugenzura ubuziranenge.

Imiti yo mu rwego rwa farumasi ya sodium carboxymethyl selulose igomba kuba yujuje ubuziranenge bwihariye, indangamuntu, hamwe n’ibisabwa byujuje ubuziranenge bigaragara muri monografiya ya farumasi (USP cyangwa EP) kandi ikubahiriza amabwiriza ya GMP kugira ngo ikoreshwe mu gukoresha imiti. Abakora inganda zo mu rwego rwa farumasi CMC bashinzwe kubungabunga amahame yo mu rwego rwo hejuru kandi bakubahiriza ibisabwa n'amategeko kugira ngo barinde ubuzima n’umutekano by’abarwayi.