Dissolution Test for Solid Oral Dosage Forms: WHO publishes Draft for Comments

Recommendation

25-27 April 2023

Leachables and Extractables - Live Online Training
Testing & Assessment from Packaging to Single Use

In the pharmaceutical industry, drug dissolution testing is routinely used as a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. A dissolution test measures the amount of drug that goes into solution over a period of time under standardized conditions. It is used to assure batch-to-batch quality, to provide process control, and to substitute in vivo studies under certain circumstances.

The World Health Organization (WHO) has now published a draft proposal for revision in The International Pharmacopoeia (Ph. Int.). The Working document QAS/20.837 from June 2020 relates to chapter 5.5 entitled DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS. A section for the analysis of suspensions and powders for oral suspension was added. Comments are sought on the new section.

The document will be posted on the WHO Medicines website under “Current Projects”. The deadline for comments is 31 August 2020.