USP 4

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Description

The flow-through dissolution method offers complete flexibility on media volumes and allows repeatable positioning of virtually all dosage forms such as powdersAPIs, lipophilic forms, suppositoriessuspensions, 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.