Content uniformity acceptance limit for a validation batch--suppositories, transdermal systems, and inhalations.
BACKGROUND
The USP test for 'Uniformity of Dosage Units' specified by USP Chapter <905> is required of every drug product sold in the United States. Dosage-unit uniformity is determined either by weight variation or by assay of individual units. The USP acceptance criteria for content uniformity states that the relative standard deviation (RSD) of a sample of 30 units should not exceed 7.8%.


OBJECTIVE
This article provides a methodology for deriving an upper acceptance limit on the RSD of dosage units from a validation batch of suppositories, transdermal systems, or inhalations such that future batches will have a 95% chance of passing the USP content uniformity RSD acceptance criterion (the RSD of 30 dosage units does not exceed 7.8%).
Senderak
Edith T
ET
Nonclinical Statistics, Merck Research Laboratories, West Point, PA 19486, USA. senderak@merck.com
D002626:Chemistry, Pharmaceutical / Q000379:methods; D004304:Dosage Forms / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000592:standards*; D010602:Pharmacopoeias as Topic; D013488:Suppositories / Q000592:standards; D014481:United States
D004304:Dosage Forms; D004364:Pharmaceutical Preparations; D013488:Suppositories