Yintoni uMahluko phakathi kwe-Apis kunye ne-Pharmaceutical Intermediates?
Zombini i-pharmaceutical intermediates kunye ne-APIs zezodidi lweekhemikhali ezilungileyo. I-Intermediates zizinto eziveliswa kwiinkqubo zamanyathelo e-APIs ekufuneka ziqhubele phambili utshintsho lwee-molecular okanye ukulungiswa ukuze zibe yi-APIs. Abaphakathi banokwahlulwa okanye bangahlulwa. (Qaphela: Esi sikhokelo sibandakanya kuphela abaphakathi abachazwa yinkampani njengoko ziveliswe emva kokuqala kwemveliso ye-API.)
Isithako esisebenzayo soxubo mayeza (API): Nayiphi na into okanye umxube wezinto ezenzelwe ukusetyenziswa ekwenzeni ichiza kwaye, xa lisetyenziswa ekwenzeni ichiza, liba sisithako esisebenzayo kwichiza. Izinto ezinjalo zinomsebenzi we-pharmacological okanye ezinye iziphumo ezithe ngqo kwi-diagnostic, unyango, ukukhululeka kweempawu, ukulawula okanye ukuthintela izifo, okanye kunokuchaphazela imisebenzi kunye nezakhiwo zomzimba. I-APIs zimveliso ezisebenzayo eziye zagqiba indlela yokudibanisa, ngelixa i-intermediate ziyimveliso kwindawo ethile ecaleni kwendlela yokudibanisa. I-APIs inokulungiswa ngokuthe ngqo, ngelixa i-intermediates ingasetyenziselwa kuphela ukudibanisa isinyathelo esilandelayo semveliso. Kuphela ngabaphakathi apho ii-APIs zinokuveliswa.
Inokubonwa kwinkcazo yokuba i-intermediates yimveliso ephambili kwi-front-end process yokwenza ii-APIs kwaye zinezakhiwo ezahlukeneyo kwii-APIs. Ukongeza, kukho iindlela zokuvavanya izixhobo eziluhlaza kwi-Pharmacopoeia, kodwa hayi kubaphakathi. Ukuthetha ngesatifikethi, okwangoku i-FDA ifuna abaphakathi ukuba babhaliswe, kodwa i-COS ayifuni. Nangona kunjalo, ifayile ye-CTD kufuneka ibe nenkcazo yenkqubo ecacileyo ye-intermediate. E-China, akukho mfuneko ye-GMP efunekayo yabaphakathi.
Abaphakathi bamayeza abafuni iilayisensi zemveliso ezifana neeAPI. Imiqobo yokungena iphantsi noko kwaye ukhuphiswano luqatha. Ke ngoko, umgangatho, isikali kunye nenqanaba lolawulo lihlala lisisiseko sokuphila nophuhliso lwamashishini. Uxinzelelo olukhulayo kukhuseleko lokusingqongileyo lubangele ukuba iinkampani ezininzi ezincinci zirhoxe ngokuthe ngcembe kwinqanaba lokukhuphisana, kwaye ukugxila kweshishini kulindeleke ukuba kunyuke ngokukhawuleza.