
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.
Shoreh Shabrang is senior consultant RA CMC, SAABAS LLC.

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.

Published: September 1st 2018 | Updated:

Published: October 3rd 2018 | Updated: