Note for Guidance for Food Contact Materials
Page 105 of 126
[CONSTITUENT] = set out 'monomer' or 'additive' or 'aid
set out numerical values of analyte concentration range
set out 'µg' or 'mg'.
set out principle of method used to determine analyte in
matrix, e.g. 'headspace gas chromatography' or 'solvent
extraction, then gas chromatography' or 'high performance
liquid chromatography', etc.
set out whether an internal standard or an external standard
is used or whether standard addition is applied.
An internal standard should be used whenever possible and
an explanation should be offered for not using one.
set out what confirmation procedure is used.
3.1 [ANALYTE ST, FORM] = set out analyte standard used for calibration, bruto formula
set out purity requirements, if any, of analyte standard.
3.2 [STANDARD, FORM] =
set out internal or external standard, bruto formula inclusive
set out purity requirements, if any, of internal standard, if
In general the internal standard should contain no impurity
at > 1% by peak area or peak height which will elute at the
same retention time as that of the analyte.
3.3 [REAGENTS] =
set out chemicals, other than anal yte standard and internal
standard or external standard and solvents involved in the
set out purity requirements, if any, of reagents and solvents,
or set out 'all reagents shall be of analytical quality'.
set out solutions, concentration inclusive, involved in the
procedure, such as:
primary solution of analyte standard
dilute solution(s) of analyte standard
solution(s) of internal or external standard
set out detailed instructions for preparation of solutions.