Analytical Method Validation

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Mayelana nalolu hlelo lokusebenza

Iyingxenye ebalulekile ye-analytical chemistry, lapha nikeza igxathu negxathu ukuthi ungayenza kanjani ukuhlaziya indlela yokuqinisekisa.

mayelana nohlelo lokusebenza

- Chaza kafushane Umhlahlandlela we-ICH wokuqinisekisa indlela yokuhlaziya
- Nikeza isibonelo sempilo ejwayelekile ukuze uqonde umqondo oyisisekelo.
- I-Analytical chemistry indlela yokuqinisekisa Umbuzo nempendulo
- I-Vedio isekela
- umbuzo we-Pharama interview kanye nempendulo unikeze umqondo wakho ukuze uqonde kangcono
- Futhi ungabeka umbuzo wethu engxoxweni noma umbhali webhokisi lombhalo uzophendula ngangokunokwenzeka.

- Ikhophi esalungiswa izokunikeza ngemikhuba yakho futhi okuhle ukuthi uhambe ukuze uthole uchwepheshe wokuqinisekisa indlela.

Isibonelo somzila wesici sohlelo lokusebenza sisho:
esinye sezibonelo sizoxoxa lapha

- Ukucaciswa (Kufundwa Kuphela)
- Incazelo
Ukucaciswa yikhono lokuhlola ngokungananazi i-analyte phambi kwezingxenye okungenzeka kulindeleke ukuthi zibe khona. Ngokuvamile lokhu kungase kuhlanganise ukungcola, okonakalisayo, i-matrix, njll.

[Impilo Yesibonelo Somshado: Lapho Intombazane eneminyaka engaba ngu-25 umzali ezobona umfana womshado Umzali uzobona lokho noma athole Imvelo yomfana (Umkhuba omubi noma Umkhuba Omuhle), impahla njll.


Lesi sibonelo uma siqhathaniswa ne-Specificity sihlola ngokungananazi i-analyte (Umkhuba Omubi noma Umkhuba Omuhle)
ubukhona bezakhi (Umfana) okungenzeka kulindeleke ukuthi zibe khona. Ngokuvamile lezi zingase(ziphuze ugwayi, iwayini njll) zihlanganisa ukungcola, okonakalisayo, i-matrix, njll.]

kuyisibonelo esisodwa nje ukukunikeza futhi abaningi abengeziwe ukunikeza lolu hlelo lokusebenza

Ngethemba ukuthi uyalujabulela uhlelo lokusebenza

Uhlobo lokuqinisekisa embonini yezemithi?
1. Ukuqinisekisa ukuhlanza
2. Ukuqinisekiswa kwenqubo
3. Ukuqinisekiswa kwemishini
4. Indlela yokuqinisekisa

Ngaphambi kokuqala ukuqinisekiswa kwendlela yokuhlaziya kufanele siqonde igama elithile eliyisisekelo

Q2A: Umbhalo mayelana nokuqinisekiswa kwenqubo yokuhlaziya kanye
I-Q2B: ukuqinisekiswa kwenqubo yokuhlaziya: Indlela yokwenza

Ngaphambilini imihlahlandlela emibili yayinekhodi Q2A kanye ne-Q2B, eyahlanganiswa kumhlahlandlela we-Q2(R1) Nov 2005.

Isifinyezo

Ukuqinisekiswa kwendlela kunikezwa ulwazi mayelana nesilinganiso sokuhlaziya njenge
· Inikeza ulwazi mayelana nenqubo
· Okomhlaziyi (umsebenzisi wenqubo)
· Okwekhasimende (the
· umsebenzisi wemiphumela)
· Imfuneko yokulawula
· Izidingo ze-ISO 17025
· Ukuqinisekisa ukufaneleka kwesistimu
· Ukuze kuhanjiswe kuqoqo
· Ukugwema Idokhumentari

Ngaphambi kokuqala indlela yokuqinisekisa ukucatshangelwa kwesidingo sangaphambili

Ukufaneleka Kwensimbi
Hlola ukufaneleka nokulinganiswa
Ukufaneleka Kwezinto Ezisetshenziswayo
Hlola Izithenjwa ezijwayelekile, ama-reagents nokuningi
Ukufaneleka Komhlaziyi
Hlola irekhodi lokuqeqeshwa kanye nerekhodi leziqu
Ukufaneleka Kwemibhalo
Gunyaza iphrothokholi noma i-SOP enemibandela yokwamukela kusengaphambili.

Imfuneko yokulawula:

Isihloko se-ICH Q 2 (R1) Ukuqinisekiswa Kwezinqubo Zokuhlaziya: Umbhalo kanye
Indlela yokwenza
<1225>UKUQINISEKISA KWEZINQUBO EZITHINTAYO

Esinye isahluko se-pharmacopeia:

〈1224〉 DLULA IZINKQUBO ZOKUHLAZIYA
[Qaphela: Dlulisa phakathi kwelabhorethri uye elabhorethri]

<1225>UKUQINISEKISA KWEZINQUBO EZITHINTAYO
[Qaphela: I-Chromatography igxila kulesi sahluko]

<1226>UKUQINISEKISA KWEZINKQUBO EZITHILE
[Qaphela: Indlela efanele kanye nesikhathi esisetshenziswayo]

Inhloso

Uhlobo lwenqubo yokuhlaziya luqinisekisiwe

· Izivivinyo zokuhlonza.
· Ukuhlolwa kwenani lokuqukethwe kokungcola.
· Nciphisa izivivinyo zokulawula ukungcola.
· Ukuhlolwa kwenani lengxenye esebenzayo kumasampula ento yomuthi noma umkhiqizo wesidakamizwa noma enye ingxenye ekhethiwe emkhiqizweni womuthi.

Izivivinyo zokuhlonza

· Ukuhlolwa kwamakhemikhali
· Indlela ye-Spectroscopic efana ne-FTIR, NMR, Mass spectroscopy njll
Amasu eChromatographic (TLC, HPTLC, HPLC)

Yini entsha

ICH guideline Q2(R2)