Technical / White Paper

Elemental Impurities Regulations View from a CRO

Published

Format: PDF file | Document type: Technical / White Paper

Elemental Impurities Regulations View from a CRO

Regulatory control of elemental impurities in pharmaceutical products has long been discussed, with both the European Pharmacopeia (EP) and the United States Pharmacopeia (USP) having planned on issuing specific chapters relating to contamination from elemental substances. New regulations have been postponed several times, most recently to take into consideration the guidance from The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). With this document now in place the relevant pharmacopeias are almost certainly finalised as to their respective approaches to the implementation of these regulations.

In this white paper, an overview will be given on how the regulations have evolved through the pharmacopeias, how the ICH has impacted these regulations, how these could be implemented by manufacturers and the role of CROs in this process.

Latest content from RSSL

show more

Extractables and leachables analysis of pharmaceutical products

Content provided by RSSL

Extractables and leachables analysis of pharmaceutical products

A crucial undertaking when releasing pharmaceutical products for the market, is to determine the purity of the final product, necessitating the need to determine its impurity profile. Traditionally, this was concerned only with those impurities arising...

The impact of particles on pharmaceuticals

Content provided by RSSL

The impact of particles on pharmaceuticals

Sometimes it's the smallest details that have the biggest impact on pharmaceutical performance. That's certainly true when it comes down to the properties of particles and their impact on pharmaceutical performance. Subtle changes in particle...

Related resources from RSSL

Show more

Supplier info centre