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In the Pharmacopeial Forum Vol. 32 (4) of July/August
2006, a revised version of the General Chapter <621> Chromatography
was published. In particular, the section regarding the system
suitability test was subject to minor changes. The reference to
General Chapter <1226> - Verification of Compendial Methods was deleted.
Chapter <621> describes which maximum adjustments can be made to an
analysis so that a method still fulfils the requirements of the system
suitability test.
The following items are listed:
- pH-value of the mobile phase: +/- 0.2 units
- Length of the HPLC column: +/- 70%
- Particle size: can be reduced by up to 50%
- Flow rate: +/- 50%
The following recent changes were made:
- Inner diameter of the column: now +/- 25% for HPLC and +/-50% for GC
- Column temperature HPLC: now +/- 10°C instead of +/-20°C
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