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Instrumental Analytical Chemistry > FDS: Method Validation > Flashcards

FDS: Method Validation Flashcards

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
Specificity / selectivity hplc
26
Specificity / selectivity monitored mass
27
Specificity / selectivity isotope ratio
28
Specificity / selectivity isotopes tungsten
29
Specificity / selectivity LC/MSMS Method blank
30
Specificity / selectivity LC/MSMS M.D.L. (spiked)
31
LINEARITY graphs
32
LINEARITY examples
33
Linear combination of parameters
34
LINEARITY Means of evaluating the linear relationship:
35
LINEARITY formulas
36
LINEARITY Arachidic acid
37
ACCURACY AND PRECISION general
38
ACCURACY AND PRECISION 3 levels
39
ACCURACY AND PRECISION (repeatibility)
40
Accuracy
41
Precision
42
Method Validation example acceptance range
43
Method Validation RESULTS SUMMARY FOR IRGANOX 1010
44
Confidence Limits
45
Confidence Limits Y?
46
Measurement uncertainty
47
Measurement uncertainty example 2
48
DETECTION LIMIT
49
Method Detection Limit (M.D.L.)
50
Method Detection Limit (M.D.L.) 2. Standard deviation
51
QUANTIFICATION LIMIT
52
DETECTION and QUANTIFICATION LIMIT (S/N)
53
Detection Limit LCMS
54
RANGE OF THE METHOD
55
ROBUSTNESS analytical method
56
ROBUSTNESS typical variations
57
SST – SYSTEM SUITABILITY TESTING
58
VALIDATION OF AN ANALYTICAL METHOD : parameters limit
59
LIMIT TEST VALIDATION
60
Methods to be used in different laboratories
61
Method Validation: method transfer
62
EURACHEM PRINCIPLES
63
when should methods be validated
64
EURACHEM PRINCIPLES selection path
65
EURACHEM PRINCIPLES analytical requirements element
66
types of bias
67
Method Validation: IUPAC Guideline definitions
68
Method Validation: IUPAC Guideline
69
Method Validation: IUPAC Guideline changes
70
Method Validation: IUPAC Guideline judgement
71
Acceptable RSD afo concentration
72
Acceptable recovery afo concentration
73
Statistical outliers
74
Statistical outliers table
75
Statistical outliers example

Instrumental Analytical Chemistry (16 decks)

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