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Working Document

(MCPD ESTERS & GE)

2

48

Limit of Detection (LOD)

49

The smallest amount or concentration of an analyte that can be estimated with acceptable

50

reliability

. Determined as: LOD = blank mean + 3 standard deviations of ten independent

51

analyses of blank or blank spiked at low level (to be agreed upon by Study Directors) (if

52

there is no detectable blank signal). See reference to Appendix L in section 7. Validation

53

Guidance.

54

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Limit of Quantitation (LOQ)

56

The minimum concentration or mass of analyte in a given matrix that can be reported as a

57

quantitative

result. Determined as: LOQ = blank mean + 10 standard deviations of ten

58

independent analyses with spiked concentration of blank to be <10% of the estimated LOQ.

59

See reference to Appendix L in section 7. Validation Guidance.

60

61

3-MCPD

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3-MCPD = 3-monochloropropane-1,2-diol or 3-chloropropane-1,2-diol. CAS NO. 96-24-2.

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See figure 1 for molecular structure.

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2-MCPD

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Include definition 2-MCPD = 2-monochloropropane-1,3-diol or 2-chloropropane-1,3-diol.

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CAS NO. 497-04-1.

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See figure 2 for molecular structure.

69

70

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glycidol

72

Include definitionglycidol = 2,3-epoxy-1-propanol. CAS NO. 556-52-5.

73

See figure 3 for molecular structure.

74

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3-MCPD esters

76

3-MCPD esters (bound 3-

MCPD) =

77

Suggestion: All 3-MCPD derivatives being present as fatty acid esters (mono- and diesters).

[Jk2]

78

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2-MCPD esters

80

2-MCPD esters (bound 2-

MCPD) =

81

Suggestion: All 2-MCPD derivatives being present as fatty acid esters (mono- and diesters).

[Jk3]

82

83

glycidyl esters

84

Include definition (include general)glycidyl esters (bound glycidol) =

85

Suggestion: All glycidyl derivatives being present as fatty acid esters (monoesters).

[Jk4]

86

87

88

Repeatability

89

Variation arising when all efforts are made to keep conditions constant by using the same

90

instrument and operator, and repeating during a short time period. Expressed as the

91

repeatability standard deviation (SD

r

); or % repeatability relative standard deviation

92

(%RSD

r

).

93

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Reproducibility

95

The standard deviation or relative standard deviation calculated from among-laboratory

96