Dissolution Testing USP 4

The flow-through dissolution method offers complete flexibility on media volumes and allows repeatable positioning of virtually all dosage forms such as powders, APIs, lipophilic forms, suppositories, suspensions, liposomes, microspheres, semi-solids, implants, and medical devices including drug eluting stents. Described in the United States Pharmacopeia (USP) as Apparatus 4, in the European Pharmacopeia (EP) as Flow-through cell, in the Japanese Pharmacopeia (JP) as Apparatus 3, in the Chinese Pharmacopeia (ChP) as Method 6, and other Pharmacopeia, dissolution and drug release testing using a flow-through cell is proven to characterize the active drug release in terms of bioequivalence and in-vitro / in-vivo correlation (IVIVC) in clinical studies and daily QC routines alike.

Biorelevance delivered.

Sometimes referred to as the "Swiss Army Knife", flow-through cells allow dissolution testing of virtually all dosage forms. SOTAX was the first manufacturer to develop a standardized flow-through dissolution tester and has ever since helped Pharmaceutical companies all over the world in designing robust flow-through methods - and new flow-through cells for novel dosage forms.

The global standard.

The SOTAX CE 7smart flow-through dissolution testing system allows you to see differences in your formulations that paddle and basket methods simply won't show. Widely recommended for poorly soluble, modified / extended release, and low dose products, the CE 7smart is also frequently used for in-vitro / in-vivo correlation (IVIVC) studies and a growing range of dosage types.



European Phamacopoeia (Ph.Eur.)

  • 2.9.3, Dissolution, Apparatus 4 (Flow-through cell)
  • 2.9.42, Dissolution test for lipophilic solid dosage forms
  • 2.9.43, Apparent dissolution
  • 5.17.1, Recommendations on dissolution testing

United States Pharmacopeia (USP)

  • USP <711>, Dissolution, Apparatus 4 (Flow-through cell)
  • USP <2040>, Dietary supplements
  • USP <1094>, Liquid filled capsules
  • USP <1724>, Semi-solids