European Pharmacopoeia specifications for the system suitability test and
for the delimitation between adjustment and modification of a method
Supplement 2001 of the third edition of the European Pharmacopoeia is a
general monograph of great importance for the scientist in the
pharmaceutical analysis laboratory.
The new monograph 2.2.46 Chromatographic Separation Techniques defines the
necessary scope of system suitability tests. This includes the symmetry
factor, the injection precision, the detection and determination limits as
well as the new peak/valley ratio (only for tests for related substances
in case of incomplete separation of an impurity from the analyte).
In addition, the test for a delimitation between adjustment of an existing
system within defined limits and modification will probably be very
important for practice and also provide an orientation within the change
control process as regards the chromatographic methods.
The new monograph lists some parameters which can be adjusted within the
framework of the system suitability test without the analysis method
counting as modified.
For the following parameters the monograph lists the limits within which
the modification of a method is still accepted as adjustment:
addition to this Ph.Eur. monograph interesting information on the system
suitability test can also be found in USP 24 (First Supplement) and in the
FDA Reviewer Guidance Validation of Chromatographic Methods of
of the mobile phase
of the aqueous component
concentration in the buffer component of the mobile phase