New European Pharmacopoeia specifications for the system suitability test and for the delimitation between adjustment and modification of a method

GMP News Nr. 91

GMP News
6 February 2001

 

New 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:

  • composition of the mobile phase
  • pH of the aqueous component
  • Salt concentration in the buffer component of the mobile phase
  • Stationary phase
  • Flow rate
  • Temperature
  • Injection volume
In 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 November 1994.
 

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