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Answer:
This requirement does not concern analytical procedures included under t= he ASSAY section of a monograph. It concerns any LC or GC purity tests stat= ed in the TESTS section of a monograph and which include a reporting thresh= old (or disregard limit).
In monographs, a reporting threshold is only stated in tests:
Therefore, this requirement is not to be applied to assays or tests that= do not include a defined reporting threshold/disregard limit.
It should be emphasised that Ph. Eur. 10th Edition version of=
the general chapter mentioned =E2=80=98in a related substances test, the l=
imit of quantification (corresponding to a signal-to-noise ratio of 10=
) is equal to or less than the disregard limit.=E2=80=99
Past experience showed that this statement was sometimes misunderstood, as =
it was wrongly interpreted to apply only to tests under the heading =E2=80=
=98Related substances=E2=80=99, although it was meant to apply to any LC or=
GC test in the TESTS section of monographs. The term =E2=80=98in a re=
lated substances test=E2=80=99 was therefore omitted in the course of the i=
nternational harmonisation work.