
In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

This article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

Published: October 2nd 2013 | Updated:

Published: September 1st 2018 | Updated:

Published: October 3rd 2018 | Updated:

Published: October 1st 2019 | Updated: