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Instrumental Analytical Chemistry > FDS: Method Validation > Flashcards

FDS: Method Validation Flashcards

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1
Q

WHAT’S THE INTENDED USE ?

general (4X)

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2
Q

WHAT’S THE INTENDED USE ?

matrix, water

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3
Q

WHAT’S THE INTENDED USE ?

matrix, possibilities

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4
Q

WHAT’S THE INTENDED USE ?

targets

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5
Q

How many targets in which matrix ?

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6
Q

How many targets ?

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7
Q

How many targets and techniques?

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8
Q

Looking at what level(s) ?

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9
Q

Looking at what level(s) ?

to what will it lead

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10
Q

Looking at what level(s) ?

Is the preset threshold a high concentration level or rather a trace concentration (at the limits of the technique)?

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11
Q

References, guidelines ……

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12
Q

Examples Need for a quantitative method (“validated”)

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13
Q

Example (hypothetical)

a drug product

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14
Q

Example (hypothetical)

informations

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15
Q

Example (hypothetical) Information from this objectives:

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16
Q

Example (hypothetical) Information from this objectives:

upper range

matrix

robustness

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17
Q

Method Validation VALIDATION OF AN ANALYTICAL METHOD : parameters

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18
Q

VALIDATION OF AN ANALYTICAL METHOD : parameters

type of analytical procedure

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19
Q

SPECIFICITY / SELECTIVITY

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20
Q

SPECIFICITY / SELECTIVITY

mass spectroscopie

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21
Q

SPECIFICITY / SELECTIVITY

non ms techniques

retention time

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22
Q

SPECIFICITY / SELECTIVITY

matrix interference

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23
Q

Specificity / selectivity

During optimization:

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24
Q

Specificity / selectivity

Technique specific (possible) criteria

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25
Q

Specificity / selectivity

hplc

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26
Q

Specificity / selectivity

monitored mass

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27
Q

Specificity / selectivity

isotope ratio

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28
Q

Specificity / selectivity

isotopes tungsten

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29
Q

Specificity / selectivity

LC/MSMS Method blank

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30
Q

Specificity / selectivity

LC/MSMS M.D.L. (spiked)

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31
Q

LINEARITY

graphs

A
32
Q

LINEARITY

examples

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33
Q

Linear combination of parameters

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34
Q

LINEARITY

Means of evaluating the linear relationship:

A
35
Q

LINEARITY

formulas

A
36
Q

LINEARITY

Arachidic acid

A
37
Q

ACCURACY AND PRECISION

general

A
38
Q

ACCURACY AND PRECISION

3 levels

A
39
Q

ACCURACY AND PRECISION (repeatibility)

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40
Q

Accuracy

A
41
Q

Precision

A
42
Q

Method Validation

example

acceptance range

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43
Q

Method Validation

RESULTS SUMMARY FOR IRGANOX 1010

A
44
Q

Confidence Limits

A
45
Q

Confidence Limits

Y?

A
46
Q

Measurement uncertainty

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47
Q

Measurement uncertainty

example 2

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48
Q

DETECTION LIMIT

A
49
Q

Method Detection Limit (M.D.L.)

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50
Q

Method Detection Limit (M.D.L.)

  1. Standard deviation
A
51
Q

QUANTIFICATION LIMIT

A
52
Q

DETECTION and QUANTIFICATION LIMIT (S/N)

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53
Q

Detection Limit

LCMS

A
54
Q

RANGE OF THE METHOD

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55
Q

ROBUSTNESS

analytical method

A
56
Q

ROBUSTNESS

typical variations

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57
Q

SST – SYSTEM SUITABILITY TESTING

A
58
Q

VALIDATION OF AN ANALYTICAL METHOD : parameters

limit

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59
Q

LIMIT TEST VALIDATION

A
60
Q

Methods to be used in different laboratories

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61
Q

Method Validation: method transfer

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62
Q

EURACHEM PRINCIPLES

A
63
Q

when should methods be validated

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64
Q

EURACHEM PRINCIPLES

selection path

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65
Q

EURACHEM PRINCIPLES

analytical requirements element

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66
Q

types of bias

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67
Q

Method Validation: IUPAC Guideline

definitions

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68
Q

Method Validation: IUPAC Guideline

A
69
Q

Method Validation: IUPAC Guideline

changes

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70
Q

Method Validation: IUPAC Guideline

judgement

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71
Q

Acceptable RSD afo concentration

A
72
Q

Acceptable recovery afo concentration

A
73
Q

Statistical outliers

A
74
Q

Statistical outliers

table

A
75
Q

Statistical outliers

example

A

Instrumental Analytical Chemistry (16 decks)

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