Choose Your USP 4 Automation Level Defining the level of automation that best fits the product and throughput requirements can help to ensure reproducibility and standardization of your dissolution test. This report summarizes some trends observed in drug dissolution testing, based upon the United States Pharmacopeia (USP) dissolution Apparatus Suitability Test results and the preliminary data obtained from an international collaborative study to assess the pharmaceutical quality of furosemide products in different countries. powder, suspensions, implants, gels, creams, microspheres, suppositories, liposomes…). The USP Apparatus II is the device commonly used to conduct dissolution testing in the pharmaceutical industry. Closed Loop The closed loop system set-up is the most used, it allows complete flexibility of volume from 15 mL to 4'000 mL and will provide cumulative data on dosage forms, which are difficult to position in a vessel in a reproducible way (e.g. The open loop is also well adapted to ER, MR, SR dosage forms due to its media selection ability which allows a pH change on the fly. Choose Your USP 4 System Set-up Open Loop The open loop system set-up is historically the one used to guarantee sink conditions (from 2 to 5 times inferior to saturation concentration) to test poorly soluble compounds. drug eluting stents, the right method is the USP 4 flow-through cell. Dissolution Testing USP 4 To benefit from complete flexibility on media volumes and to reproducibly position dosage forms, the right method is the USP 4. suppositories, suspensions, liposomes, microspheres, semi-solids, implants and medical devices e.g. To benefit from complete flexibility on media volumes and to reproducibly position dosage forms such as powders, APIs, lipophilic forms e.g.

Dissolution test usp