During the meeting of the ICH Steering Committee in St. Louis, Missouri, in October 2009 five annexes to the ICH Q4B Guideline could be brought a step closer to their finalisation.

At the meeting, three guidelines reached Step 4:

• Annex 7: Dissolution Test: http://www.ich.org/LOB/media/MEDIA5778.pdf
• Annex 9: Tablet Friability: http://www.ich.org/LOB/media/MEDIA5779.pdf
• Annex 10: Polyacrylamide Gel Electrophoresis: http://www.ich.org/LOB/media/MEDIA5780.pdf

And two guidelines reached Step 2:

• Annex 11: Capillary Electrophoresis: http://www.ich.org/LOB/media/MEDIA5781.pdf
• Annex 12: Analytical Sieving: http://www.ich.org/LOB/media/MEDIA5782.pdf

With regard to the guidelines on capillary electrophoresis, the following descriptions of the analytical methods are considered as interchangeable:

• Ph.Eur. 2.2.47 Capillary Electrophoresis
• JP General Information 4. Capillary Electrophoresis
• USP General Information Chapter <1053> Biotechnology-derived Articles - Capillary Electrophoresis

And in the new Annex 12 on analytical sieving, the following pharmacopoeial methods are mentioned:

• USP General Chapter <786> Particle Size Distribution Estimation by Analytical Sieving
• Ph.Eur. 2.9.38 Particle-size Distribution Estimation by Analytical Sieving
• JP 3.04 Particle Size Determination entitled Method 2. Analytical Sieving Method

As an addition to this Annex 12, there is a detailed Appendix A with an excerpt form the Japanese Pharmacopoeia bearing the title "Draft JP XV Supplement II English Text Provided by MHLW / 3.04 Particle Size Determination".

Author:
Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)