Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms

The United States Pharmacopeia General Chapter <905>, “Uniformity of Dosage Units,” describes requirements for oral solid dosage formulations greater than 25mg/25% threshold. This chapter shows that it may be risky to release routine batches using weight variation (WV) instead of the content uniformity (CU) method; although, it is allowed by the monograph. To prevent risk to quality, justification of WV data quality in process validation (PV) batches is necessarily required to ensure that each of the routine batches released by WV meets the monograph requirements. A practical approach to using available statistical techniques for demonstration of interchangeability between CU and WV data in the same PV batches is introduced.

Peer-reviewed research

Submitted: Jan. 3, 2023
Accepted: Jan. 25, 2023

About the author

Pramote Cholayudth, cpramote2000@yahoo.com, is the founder and manager of PM Consult. He is an industrial pharmacist with more than 40 years of experience. He is a guest speaker on process validation to industrial pharmaceutical scientists organized by Thailand’s FDA.

Article Details

Pharmaceutical Technology
Vol. 47, No. 3
March 2023
Pages 34–39

Citation

When referring to this article, please cite it as Cholayudth, P. Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms. Pharmaceutical Technology 2023, 47 (3), 34–39.