title: Particle size and content uniformity.
abstract: The requirements of the USP Content Uniformity test are translated into physical and mathematical parameters. Assuming spherical particle sizes with a log normal distribution, the mean particle size and particle size distribution required to insure a high probability of passing the content uniformity test are calculated. On the basis of these calculations it is shown that satisfactory tablets of low doses cannot be manufactured from a drug that does not meet certain particle size distribution specifications. It is recommended that particle size specifications for low dose drugs include a requirement for a limit to size distribution.
authors.affiliation: College of Pharmacy, University of Arizona, Tucson 85721.
authors.forename: S H
authors.initials: SH
authors.lastname: Yalkowsky
authors.forename: S
authors.initials: S
authors.lastname: Bolton
mesh_terms: D010316:Particle Size; D011336:Probability; D013607:Tablets
chemical_list: D013607:Tablets