Also initiates a reference library for nanomaterials

 

A European standards organization has produced the first reference material for a nanoparticle and has launched a repository for reference nanomaterials. According to the director of the European Commission Joint Research Centre (JRC), the availability of these reference standards for nanomaterials will help to increase safety and quality control in the field of pharmaceutical manufacture.

 

“Carriers at the nanoscale are increasingly used for drug delivery. The size of the carrier may influence bioavailability of the drug substance. Therefore, proper control of the size of such carriers is necessary to ensure constant product quality,” said Krzysztof Maruszewski, PhD, director of the Institute for Reference Materials and Measurements, in an e-mail to PFQ.

 

The JRC’s initial reference material consists of silica nanoparticles of a nominal diameter of 20 nanometers. The nanomaterials repository contains a representative range of 25 types of reference nanomaterials, including carbon nanotubes, silver nanoparticles, titanium dioxide, cerium oxide, zinc oxide, bentonite, gold, and silicon dioxide, according to the JRC.

 

Dr. Maruszewski said the silica reference material is meant to be used as a quality assurance tool, “to demonstrate that the [manufacturer’s] size measurement itself is working properly, i.e., that the measurement result indeed reflects reality.”

 

Regarding harmonization with other standards bodies, Dr. Maruszewski said the reference material was created according to the International Organization for Standardization’s requirements, the same principles used by the United States Pharmacopoeia.

 

“Other producers have not yet released certified reference materials for real-life nanoparticles produced according to the same stringent rules,” he said. “This means the material can directly apply worldwide and is not limited to any geographical region.”

 

SOURCE:PFQ