Focus on Cellulose ethers

USP, EP, GMP pharmaceutical ọkwa Sodium CMC

USP, EP, GMP pharmaceutical ọkwa Sodium CMC

Sodium carboxymethyl cellulose (CMC) nke a na-eji na ngwa ọgwụ ga-emerịrị ụfọdụ ụkpụrụ dị mma iji hụ na nchekwa ya, ịdị mma, na adabara maka iji na ngwaahịa ọgwụ.United States Pharmacopeia (USP), European Pharmacopoeia (EP), na Ezi Nrụpụta Omume (GMP) ntuziaka na-enye nkọwapụta na ihe achọrọ maka ọkwa ọgwụ CMC.Nke a bụ ka ụkpụrụ ndị a si emetụta CMC ọkwa ọgwụ:

  1. USP (United States Pharmacopeia):
    • USP bụ nchịkọta zuru oke nke ụkpụrụ ọgwụ na-agụnye nkọwapụta maka ngwa ọgwụ, ụdị usoro onunu, na usoro nnwale.
    • USP-NF (United States Pharmacopeia-National Formulary) monographs na-enye ụkpụrụ maka sodium carboxymethyl cellulose, gụnyere ihe ndị a chọrọ maka ịdị ọcha, njirimara, nyocha, na àgwà ndị ọzọ.
    • CMC-ọkwa ọgwụ ga-agbasorịrị nkọwapụta akọwapụtara na monograph USP iji hụ na ịdịmma ya, ịdị ọcha ya na dabara adaba maka iji ọgwụ.
  2. EP (European Pharmacopoeia):
    • EP bụ ihe nchikota nke ụkpụrụ maka ngwaahịa na ihe ndị na-emepụta ọgwụ, nke a ghọtara na Europe na ọtụtụ mba ndị ọzọ.
    • EP monograph maka sodium carboxymethyl cellulose na-akọwapụta ihe achọrọ maka njirimara ya, ịdị ọcha ya, akụrụngwa physicochemical na ogo microbiological.
    • Pharmaceutical-ọkwa CMC ezubere maka ojiji na Europe ma ọ bụ mba ndị na-agbaso ụkpụrụ EP ga-emezurịrị nkọwapụta akọwapụtara na monograph EP.
  3. GMP (Ụmụ Nrụpụta Ọma):
    • Ntuziaka GMP na-enye ụkpụrụ na ihe achọrọ maka nrụpụta, nnwale na njikwa mma nke ngwaahịa ọgwụ.
    • Ndị na-emepụta CMC-ọkwa ọgwụ ga-agbasorịrị ụkpụrụ GMP iji hụ na mmepụta ngwaahịa dị elu yana nchekwa na-agbanwe agbanwe.
    • Ihe GMP chọrọ na-ekpuchi akụkụ dị iche iche nke nrụpụta, gụnyere imewe ụlọ, ọzụzụ ndị ọrụ, akwụkwọ, nkwado usoro, na usoro njikwa mma.

sodium carboxymethyl cellulose nke ọkwa ọgwụ ga-ezuterịrị ịdị ọcha, njirimara, na ịdịmma chọrọ nke akọwapụtara na monographs pharmacopeial dị mkpa (USP ma ọ bụ EP) wee rube isi n'iwu GMP iji hụ na ọ dabara maka ojiji na usoro ọgwụ.Ndị na-emepụta ọgwụ-ọkwa CMC na-ahụ maka idowe ụkpụrụ ịdị mma kachasị elu yana hụ na nrube isi n'usoro iwu chọrọ iji chekwa ahụike na nchekwa onye ọrịa.


Oge nzipu: Mar-07-2024
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