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Particle size and content uniformity.

S H Yalkowsky·S Bolton
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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.

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S H Yalkowsky, S Bolton. 1990. Particle size and content uniformity.. https://doi.org/10.1023/a%3A1015958209643

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