 Dissolution Testing of Immediate Release Solid Oral Dosage Forms by the FDA

Primary guidance: www.fda.gov/media/70936/download . Food and Drug Administration, Center for Drug Evaluation and Research, August 1997. Appendix A, printed pp. A-1–A-2, describes basket, paddle and flow-through apparatus, medium selection and agitation. The Dissolution Medium subsection states that sink conditions are desirable but not mandatory. Used as a dated technical source, not as a claim about current binding requirements.