2009 Trends in Small-Volume Dissolution Apparatus for Low-Dose Compounds

hydrodynamics, the apparatus must maintain overall physical uniformity and alignment throughout the test. Standard dissolution apparatus may be obtained from manufactures that produce the equipment according to the specification and tolerances outlined in General Test Chapter <711> Dissolution (2). For low concentrations of API, official compendial apparatus may be incapable of maintaining quantitative levels of analyte during the dissolution of oral dosage units containing microgram or nanogram levels. Dissolution of typical high-potency, low-dose compounds may require a reduction in vessel volume accompanied by an alteration in apparatus design due to limitations in detection and quantitation. If a reduction in volume is considered and the apparatus is modified, the operatin