Sample content uniformity acceptance limit tables

October 2, 2007

These sample tables supplement the article by James S. Bergum, PhD, and Hua Li, PhD, titled "Acceptance Limits for the New ICH USP 29 Content-Uniformity Test" in Pharmaceutical Technology's October 2007 issue.

These sample tables supplement the article by James S. Bergum, PhD, and Hua Li, PhD, titled "Acceptance Limits for the New ICH USP 29 Content-Uniformity Test"

Sample content uniformity acceptance limit tables

Tables assume that the target (i.e., the average of potency specification) is 100% and that the sampling plan is to test one dosage unit from each of n separate locations throughout the batch. Passing the tabled limit ensures, with the chosen level of confidence, that there is at least a 95% chance of passing the USP uniformity of dosage units test ‹905› for samples taken from that batch.