European Recommendations on Dissolution Testing

In the July 2008 issue of PHARMEUROPA, the draft for a new general chapter 5.17.1 titled "Recommendations on Dissolution Testing" was published.

The following explanation precedes the chapter: "This chapter includes recommendations on dissolution testing. Currently, this text can be found at the end of chapter 2.9.3, Dissolution Testing for Solid Dosage Forms, the rest of which has been harmonised at international level. The part that will now contain the recommendations is exclusively Ph.Eur. text.

In order to clarify the status of this text, it has been decided to create a separate general chapter in the European Pharmacopoeia.

Right at the beginning of this new chapter 5.17.1., it is clarified once more that this chapter is not binding. It contains information on

• dissolution testing, 
• recommended media for testing 
• and specifications for oral dosage forms

This chapter includes generally accepted parameters used in dissolution.

In addition, regarding the contents, the acceptance criteria were described in more concrete terms. With reference to dosage forms with conventional dissolution, e.g., the text says: "The acceptance criteria are at least 80 per cent of the active ingredient within a defined time, usually less than 45 minutes. This equals a Q value of 75%."

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