USP General Chapter <905> Uniformity of Dosage Units is internationally harmonized and has been official since USP 34–NF 29 (2011). A “Test by Values” approach is used in this harmonized chapter to assess the uniformity of dosage units. This webinar will explain, through various case studies, the calculation of the Acceptance Value, which is a critical step of the “Test by Values” approach—this webinar will also discuss the application of USP General Chapter <905> to various dosage forms.

Subject area:
Drug Products & APIs

Objectives (If applicable):
Explain the rationale of the current harmonized compendial approach to the problem of uniformity of dosage units
Calculate the Acceptance Value in determining conformance with the acceptance criteria
Describe and use the concepts of the Acceptance Value, L1 and L2, Target Value, Reference Value, and Acceptability Constant
Apply USP–NF General Chapter <905> to various types of formulations
Determine when to use the “Weight Variation Test” and when to use the “Content Uniformity Test”
Understand how to extend USP <905> to large sample sizes.
Determine a batch release strategy to ensure compliance with USP <905>

Target Audience (If applicable):
– Analytical chemists
– QC managers
– QA managers
– Compliance managers
– Lab managers
– Production managers
– Regulatory affairs specialists
– R&D scientists