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verslag validatiedossier sop sangria
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- Institution
validatiedossier met juistheid herhaalbaarheid van het sop van farma III laatste deel
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Odisee - TechnologiecampusGent
Studiegebied Gezondheidszorg
Opleiding Biomedische Laboratoriumtechnologie
AJ 2020-2021
Validatiedossier: alcohol bepaling
in mango geweekt in sangria
door middel van GC-FID
Labo farmaceutische analyse VI
3FBTB
Jelle Coppens
Kyana Couckhuyt
Yilska Smet
,2
3FBTB Jelle Coppens - Kyana Couckhuyt - Yilska Smet
, Inhoudsopgave
Validatiedossier: alcohol bepaling in mango geweekt in sangria door middel van GC-FID...............................1
1. Lineariteit................................................................................................................................................. 4
1.1. Kalibratielijn.................................................................................................................................................4
1.1.1. Opstellen verdunningsreeks en kalibratielijn........................................................................................4
1.1.2. Resultaten kalibratielijn.........................................................................................................................4
1.2. Uitschieters...................................................................................................................................................5
1.3. Correlatiecoëfficient......................................................................................................................................6
1.4. Variantieanalyse...........................................................................................................................................7
1.4.1. T-test op lineariteit................................................................................................................................7
1.4.2. T-test op richtingscoëfficiënt.................................................................................................................7
1.4.3. T-test op het snijpunt............................................................................................................................7
1.5. Besluit...........................................................................................................................................................7
2. LOD en LOQ............................................................................................................................................... 8
2.1. Resultaten + berekeningen...........................................................................................................................8
2.2. Besluit LOD en LOQ.......................................................................................................................................8
3. Juistheid................................................................................................................................................... 8
3.1. Theoretische bepaling juistheid....................................................................................................................8
3.2. Besluit juistheid.............................................................................................................................................9
4. Herhaalbaarheid....................................................................................................................................... 9
4.1. Berekeningen + resultaten herhaalbaarheid..............................................................................................10
4.2. Besluit herhaalbaarheid..............................................................................................................................11
5. Intralabreproduceerbaarheid.................................................................................................................. 11
5.1. Berekeningen + resultaten interlabreproduceerbaarheid..........................................................................11
5.2. Besluit interlabreproduceerbaarheid..........................................................................................................14
6. Onbekende............................................................................................................................................. 14
6.1. Protocol.......................................................................................................................................................14
6.2. Resultaten + berekeningen.........................................................................................................................14
6.3. Besluit onbekende.......................................................................................................................................18
7. Besluit..................................................................................................................................................... 19
8. Bronnen.................................................................................................................................................. 19
9. Bijlagen................................................................................................................................................... 20
3
3FBTB Jelle Coppens - Kyana Couckhuyt - Yilska Smet
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