APIS yog cov koom tes tseem ceeb ntawm kev tsim khoom lag luam, thiab lawv cov khoom zoo yog cuam tshuam nrog kev nyab xeeb thiab kev ua tau zoo ntawm cov tshuaj tiav. Txhawm rau kom paub meej tias APIs ua raws li cov kws tshuaj ntsuam thoob tebchaws thiab cov txheej txheem thoob ntiaj teb, kev ntsuas kev ntsuas uas yuav tsum tau tswj hwm cov qib kev tswj hwm zoo uas npog tag nrho kav.
Thawj kauj ruam hauv API kev sim yog kuaj. Raws li cov yam ntxwv sib xws thiab chaw cia khoom, cov tub rog yuav tsum xaiv cov qauv sawv cev uas paub meej tias cov qauv piv txwv ntawm tag nrho cov pob ntawm appis. Kev kuaj mob yuav tsum tau ua raws li cov kev xav tau xws li ib puag ncig ib puag ncig kom tsis txhob hla kev-}} kev hloov pauv ntawm lub cev.
Kuaj cov physicochemical Testing yog cov kauj ruam tseem ceeb, suav nrog kev tsom xam ntawm APK cov khoom, solubility, melting point, pH, thiab lwm yam tsis sib haum. High - Kev ua kua chromatography (HPLC) thiab kev faib tawm cov ntsiab lus tseem ceeb, ua kom muaj qhov ntsuas pom kev txwv. Tsis tas li ntawd, Karl Fischer Seemtic lossis HeadSpace kev ua piv txwv yog yuav tsum tau kom muaj nuj nqis rau xws li ya raws thiab muaj cov kuab tshuaj ya raws. Kev kuaj kev nyab xeeb tsom rau cov hlau hnyav, microbial txwv, thiab endotoxin tswj. Atomic nqus spectrometry (AAS) lossis inductively coupled coedplometry (icp} ms) yog siv los kuaj cov khoom muaj kev phom sij xws li txhuas thiab arsenic. Kev kuaj microbial, siv membrane pom los yog kab lis kev cai phaj phaj, ntsuas qhov kev pheej hmoo ntawm kev paug nrog cov kab mob tag nrho, fungi, thiab cov kab ke tshwj xeeb. Rau cov tshuaj APIs, endotoxin kuaj cov kev lim hiam
Kev soj ntsuam kev ruaj khov yog kev sim thoob plaws hauv tag nrho cov txheej txheem, ntsuas cov kev ua tau zoo ntawm api nyob rau hauv txawv txav ntawm kev kuaj kub thiab ntev {{}} sim qauv kuaj. Cov ntaub ntawv tau siv los txiav txim siab cov hnub so thiab kev cia khoom, muab kev tshawb fawb rau kev txhim kho ntau ntxiv.
Tag nrho cov txheej txheem kev sim siab rau cov txheej txheem kev ua haujlwm ua haujlwm (sops) thiab hla} {0} {{0} - Kev Ntsuam Xyuas Kev Ntsuas Nrog Kev Ntsuam Xyuas Kev Ntsuam Xyuas. Qhov ntau {{2} txheej, mult {{{{{{{{{{{{} Kev Ntsuas Cov Khoom Siv Rau Cov Khoom Siv Khoom Siv Cov Khoom Siv Khoom Siv Downstram.