New USP Draft for General Chapter <621> Chromatography with Impact on HPLC System Suitability Tests

GMP News No. 822

GMP News
23 October 2006
 

New USP Draft for General Chapter <621> Chromatography with Impact on HPLC System Suitability Tests

 
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

   

The requirements on the system suitability test laid down in the pharmacopoeias (USP and Ph.Eur.) are one of the focus topics of the HPLC education course organised by CONCEPT HEIDELBERG on behalf of the European Compliance Academy: "Successful HPLC Management in a GMP-/FDA-Regulated Environment" in Prague on 22-23 November 2006. An optional workshop held on 24 November 2006 deals with the validation of chromatographic data systems.

 
Author:
Dr Günter Brendelberger
On behalf of ECA
  

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