This course discusses revisions made to USP–NF General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures. In addition to presenting and discussing the necessary changes, a brief description of methods and how limits apply to products will be addressed in the course. The guidance published by the Food and Drug Administration (FDA) in June 2016 and the implementation timeline that has led to the current standards will be discussed along with risk-based approach.
Couse Duration (hh:mm:ss): 04:59:26
Chair, USP Chemical Analysis Expert Committee