Dissolution Test for Solid Oral Dosage Forms: WHO publishes Draft for Comments
Recommendation
13-15 May 2025
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
Register now for ECA's GMP Newsletter
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.
Related GMP News
09.05.2025New ECA Guidance on Sampling and Sample Management
07.05.2025Public Consultation on ICH M13B Guideline on Bioequivalence launched in Switzerland
07.05.2025BioPhorum publishes Guidance for ICH Q2(R2) and Q14 Implementation
23.04.2025OTC Drug Production Ceased after FDA Warning Letter
23.04.2025EMA publishes Draft of ICH M13B Guideline on Bioequivalence
16.04.2025EMA publishes four new product-specific Bioequivalence Guidance