1. Cim
(1) Cov tsos mob, xim, tsw, saj, crystallinity thiab lwm yam tsos, xim, tsw, saj, crystallinity thiab lwm yam ntxwv ntawm cov tshuaj, yuav tsum tau soj ntsuam, thiab yuav tsum tau saib xyuas seb puas muaj kev hloov nyob rau hauv lub sij hawm cia. , yog tias muaj kev hloov pauv, nws yuav tsum tau piav qhia qhov tseeb, xws li lub teeb hloov pauv, yooj yim nqus dej, huab cua, volatilization, thiab lwm yam.
(2) Solubility
Lub solubility ntawm cov tshuaj nyob rau hauv dej thiab feem ntau siv cov kuab tshuaj (cov kuab tshuaj uas yog ze ze rau lub solubility zog ntawm cov tshuaj, xws li cov siv nyob rau hauv kev npaj ntawm kev npaj, npaj kev daws teeb meem los yog refining hauj lwm, thiab lwm yam).
(3) Melting point lossis melting nrug
Melting point lossis melting nrug yog ib qho tseem ceeb ntawm lub cev tsis tu ncua ntawm cov tshuaj API nrog cov qauv paub, thiab cov ntaub ntawv melting point lossis melting nrug yog ib qho ntawm cov ntsuas purity rau kev txheeb xyuas thiab txheeb xyuas API. API uas yog nyob rau hauv ib tug ruaj khov lub xeev ntawm chav tsev kub yuav tsum tau soj ntsuam rau nws melting point los yog melting, decomposition thiab softening tom qab cua sov. Crystalline APIs feem ntau yuav tsum muaj qhov pom meej meej meej, thiab cov txheej txheem kev ntsuas cua sov yuav tsum tau siv rau kev tshawb fawb sib piv ntawm ntau yam uas nyuaj rau txiav txim siab qhov melting point lossis yaj thiab decompose tib lub sijhawm.
(4) Kev hloov kho qhov muag lossis kev sib hloov tshwj xeeb
Kev sib hloov kho qhov muag lossis kev sib hloov tshwj xeeb yog qhov ntsuas uas qhia txog cov khoom siv sab hauv ntawm cov khoom siv kho qhov muag thiab lawv cov purity. Rau cov tshuaj no, cov khoom sib hloov kho qhov muag (nrog cov kuab tshuaj sib txawv) yuav tsum tau tshawb xyuas, thiab kev sib hloov kho qhov muag lossis kev sib hloov tshwj xeeb yuav tsum tau txiav txim siab.
2. Kev txheeb xyuas
Kev kuaj xyuas tus kheej ntawm API yuav tsum tau txais ib txoj hauv kev uas muaj qhov tshwj xeeb muaj zog, siab rhiab heev, rov ua haujlwm zoo thiab ua haujlwm yooj yim, thiab cov kev siv feem ntau yog cov tshuaj tiv thaiv kab mob, chromatography thiab spectroscopy.
3. Kev tshuaj xyuas
Kev tshuaj xyuas feem ntau yuav tsum xav txog kev nyab xeeb, kev ua tau zoo, thiab kev huv. Cov impurities uas yuav tsum tau tswj tej zaum yuav tshwm sim nyob rau hauv cov txheej txheem ntawm ntau lawm thiab ib txwm cia cov tshuaj raws li cov txheej txheem tsim, nrog rau cov txheej txheem impurities, degradation khoom, isomers thiab residual kuab tshuaj, thiab lwm yam, yog li ntawd nws yog tsim nyog los ua zoo tshawb fawb thiab tsim impurity. tswj cov khoom uas tuaj yeem cuam tshuam qhov zoo ntawm cov tshuaj ua ke nrog cov xwm txheej tiag tiag kom ntseeg tau tias muaj kev nyab xeeb thiab ua haujlwm zoo ntawm cov tshuaj.
4. Kev txiav txim siab ntawm cov ntsiab lus (potency).
Kev txiav txim siab ntawm cov ntsiab lus ntawm cov tshuaj los ntawm lub cev thiab tshuaj txoj hauv kev yog hu ua "kev txiav txim siab cov ntsiab lus", thiab kev txiav txim siab ntawm cov tshuaj potency los ntawm cov txheej txheem lom neeg lossis cov tshuaj enzymatic yog hu ua "potency determination".
Kev txiav txim siab ntawm cov ntsiab lus (potency) ntawm cov tshuaj APIs yog ib qho ntawm cov cim tseem ceeb los ntsuas qhov zoo ntawm cov tshuaj, thiab cov txheej txheem tsim nyog yuav tsum raug xaiv los kawm cov ntsiab lus (potency) ntawm APIs.