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Note for Guidance for Food Contact Materials
Page 107 of 126
(DESCRIPTION) =
set out calibration sample preparation.

5.3 Blank sample preparation:
(DESCRIPTION) =
set out blank sample preparation.

6. PROCEDURE:

6.1 [TECHNIQUE]
parameters:
[TECHNIQUE] =
set out 'GC' or 'HSGC' or 'HPLC', etc.

(DESCRIPTION) =
set out established parameters or guidance parameters, e.g.
injector/column/detector tempera-ture, carrier gas and flow
rate, etc.

6.2 Optimisation
of
instrumentation:
(DESCRIPTION) =
set out optimisation of instrumentation.

Note 8:
For methods involving GC or HPLC, optimisation will be
required in terms of demonstrating adequate specificity and
sensitivity. The satisfactory choice of column should be
demonstrated, and optimum instrumental parameters should
be established, such as:
- injector
temperature
- column
temperature
- detector
voltage/wavelength
- detector
temperature
-
detector gas flow rate(s)
-
carrier gas/elution solvent
-
carrier gas flow rate/elution solvent flow rate
- etc.
Some indication should be given of the minimum requirement in terms of detector
performance, e.g.: should be able to detect 20 pg on-column of analyte at a signal to noise
ratio of 5:1.

6.3 Calibration:
(DESCRIPTION) =
set out in what way calibration is achieved.

i.
By calibration graph using an internal or external standard:
-
the calibration graph shall be constructed from at least five measurements
-
concentration range of analyte calibration solutions shall span from x 0.1
specific migration limit (SML) or x 0.1 residual content limit (QM) to x 2.0
SML or x 2.0 QM
-
the calibration graph shall be rectilinear
-
the correlation coefficient shall be 0.996 or better.