Ib qho nruab nrab yog ib yam khoom uas tsim nyob rau hauv cov txheej txheem ntawm API thiab yuav tsum tau mus ntxiv molecular hloov los yog refining los ua tus API, thiab cov intermediate tuaj yeem sib cais lossis tsis sib cais. Lub active ingredient yog ib tug active ingredient uas tau raug synthesized thiab tau synthesized rau kev siv tshuaj. Intermediates tsuas yog siv los ua ke cov khoom tom ntej, dhau los ntawm API tuaj yeem tsim, thaum API tuaj yeem tsim ncaj qha.
Active Pharmaceutical Ingredient (Active Pharmaceutical Ingredient): Ib yam khoom lossis sib xyaw ntawm cov khoom siv rau kev tsim cov khoom lag luam thiab, thaum siv hauv cov khoom lag luam, dhau los ua cov khoom muaj nyob hauv cov khoom lag luam tshuaj. Cov tshuaj no muaj cov tshuaj pharmacological lossis lwm yam cuam tshuam ncaj qha rau hauv kev kuaj mob, kev kho mob, kev kho mob, kev kho lossis kev tiv thaiv kab mob, lossis tuaj yeem cuam tshuam rau kev ua haujlwm thiab cov qauv ntawm lub cev. APIs yog cov khoom lag luam uas tau ua tiav cov txheej txheem hluavtaws, thaum cov khoom nruab nrab yog cov khoom siv nyob rau hauv txoj kev hluavtaws. APIs tuaj yeem tsim ncaj qha, thaum cov khoom nruab nrab tsuas yog siv los ua ke cov khoom tom ntej, thiab APIs tsuas yog tsim los ntawm cov neeg nruab nrab.
Los ntawm cov ntsiab lus, nws tuaj yeem pom tias cov khoom nruab nrab yog cov khoom tseem ceeb ntawm cov txheej txheem dhau los ntawm kev ua APIs, uas txawv ntawm cov qauv ntawm APIs. Tsis tas li ntawd, muaj txoj hauv kev tshawb nrhiav APIs hauv cov tshuaj pharmacopoeia, tab sis tsis muaj qhov nruab nrab. Hais txog kev lees paub, FDA tam sim no xav kom cov neeg nruab nrab yuav tsum tau sau npe, tab sis COS tsis ua, tab sis yuav tsum muaj cov txheej txheem ntxaws ntxaws ntawm cov intermediates hauv CTD daim ntawv. Hauv Suav teb, tsis muaj qhov yuav tsum tau ua GMP rau cov neeg nruab nrab.
Pharmaceutical intermediates tsis tas yuav muaj daim ntawv tso cai ntau lawm xws li APIs, thiab kev nkag teb chaws yog qhov tsawg thiab kev sib tw hnyav. Yog li ntawd, kev ua tau zoo, nplai thiab kev tswj hwm qib feem ntau yog lub hauv paus ntawm kev lag luam ciaj sia thiab kev loj hlob, thiab kev nce siab ntawm kev tiv thaiv ib puag ncig kuj tau ua rau ntau lub lag luam me maj mam thim tawm ntawm theem kev sib tw, thiab kev lag luam concentration yuav tsum nce sai. Nws yog feem ntau ntseeg hais tias peb cov lus qhia hauv qab no yuav yog tus yuam sij rau kev txhim kho cov txiaj ntsig, ua kom muaj txiaj ntsig ntxiv thiab kev loj hlob ntawm cov lag luam muaj feem xyuam nrog:
(1) Cov khoom sib txawv thiab siab -kawg, los ntawm kev tsim cov khoom siv qis heev -kawg intermediates mus rau nplua siab - cov khoom nruab nrab kawg;
(2) Siv txoj hauv kev ntawm cov kev pabcuam kev tshaj lij, txuas ntxiv txuas ntxiv hauv kev pabcuam kev pabcuam kev lag luam, thiab lees paub R & D cov kev pabcuam outsourcing;
(3) Tsom ntsoov rau cov kws kho mob thiab tawm tsam APIs thiab kev npaj cov dej hauv nruab nrab.