Particle size and content uniformity.
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.
Yalkowsky
S H
SH
College of Pharmacy, University of Arizona, Tucson 85721.
Bolton
S
S
D010316:Particle Size; D011336:Probability; D013607:Tablets
D013607:Tablets