Articles by James S. Bergum - Pharmaceutical Technology

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Articles by James S. Bergum

James S. Bergum


Acceptance Limits for the New ICH USP 29 Content-Uniformity Test
October 2, 2007

Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.

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