Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Don't Give the Slightest Chance to Toxic Elements in Medicinal Products

23.03.2018

New high-accuracy reference solutions for the SI-traceable measurement of inorganic contaminants allow for international comparability.

Lead, cadmium, mercury, and arsenic do not belong in medicinal products. International requirements for the quality of medicines have therefore become more stringent and introduced new control requirements.


Since January 2018, the jointly developed reference solutions for lead, cadmium, mercury, and arsenic with SI-traceable element content are in the EDQM product portfolio.

PTB

Hence, it makes sense to use high-accuracy reference solutions with defined contents of these four elements to be able to make the measurements traceable to the International System of Units (SI). Such reference solutions have now been produced in a joint project of the European Directorate for the Quality of Medicines and HealthCare (EDQM), the Joint Research Center (JRC) Geel, the German Federal Institute for Materials Research and Testing (BAM) and the Physikalisch-Technische Bundesanstalt (PTB). Since January 2018, they are commercially available at the EDQM.

The protection of public health is very high on the agenda of regulators worldwide. For this reason, it is expedient to apply the best methods available when it comes to examining medicinal products for possible contaminations.

... more about:
»BAM »EDQM »JRC »PTB »analytical instruments »toxic elements

In this case, the best means are elaborately prepared reference solutions with a defined content of toxic elements that are applied for calibrating the analytical instruments used. This way the measurements become traceable to the SI and they fulfill the specifications of the internationally harmonized quality guideline ICH Q3D, which has also been adopted by the European Medicines Agency (EMA/CHMP/ICH/353369/2013).

For the currently 38 member states of the European Pharmacopoeia (Ph. Eur.), inclusion of the guideline into the Ph. Eur. has rendered it legally binding. Since June 2016, the comparable measurements have to be applied for new medicines, and as of December 2017, this applies also to already authorized products.

In this two-year period, high-accuracy reference solutions for four particularly toxic inorganic contaminants, namely lead, cadmium, mercury, and arsenic were produced within the framework of this European cooperation. In January 2018, the solutions have been included in the portfolio of the EDQM, and are now commercially available (https://crs.edqm.eu/).

“The preparation of such high-accuracy monoelemental reference solutions requires years of experience,” stated Dr. Anita Röthke, chemist at PTB. “BAM and PTB have been active in this field for two decades and can therefore prepare and characterize these solutions at an especially high accuracy level.” When characterizing the mass fraction of lead in the solution by means of ICP OES (optical emission spectrometry with inductively coupled plasma), PTB was, for example, able to achieve measurement uncertainties one hundred times smaller than usually obtained in routine measurements.

Currently, there are discussions on continuing the successful collaboration efforts with the objective of developing further reference solutions.
es/ptb

Contact
Dr. Anita Röthke, PTB Working Group 3.11 “Inorganic Analysis”, phone: +49 531 5923179, e-mail: anita.roethke@ptb.de

Imke Frischmuth | idw - Informationsdienst Wissenschaft
Further information:
http://www.ptb.de/

Further reports about: BAM EDQM JRC PTB analytical instruments toxic elements

More articles from Life Sciences:

nachricht Complete skin regeneration system of fish unraveled
24.04.2018 | Tokyo Institute of Technology

nachricht Scientists generate an atlas of the human genome using stem cells
24.04.2018 | The Hebrew University of Jerusalem

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: BAM@Hannover Messe: innovative 3D printing method for space flight

At the Hannover Messe 2018, the Bundesanstalt für Materialforschung und-prüfung (BAM) will show how, in the future, astronauts could produce their own tools or spare parts in zero gravity using 3D printing. This will reduce, weight and transport costs for space missions. Visitors can experience the innovative additive manufacturing process live at the fair.

Powder-based additive manufacturing in zero gravity is the name of the project in which a component is produced by applying metallic powder layers and then...

Im Focus: Molecules Brilliantly Illuminated

Physicists at the Laboratory for Attosecond Physics, which is jointly run by Ludwig-Maximilians-Universität and the Max Planck Institute of Quantum Optics, have developed a high-power laser system that generates ultrashort pulses of light covering a large share of the mid-infrared spectrum. The researchers envisage a wide range of applications for the technology – in the early diagnosis of cancer, for instance.

Molecules are the building blocks of life. Like all other organisms, we are made of them. They control our biorhythm, and they can also reflect our state of...

Im Focus: Spider silk key to new bone-fixing composite

University of Connecticut researchers have created a biodegradable composite made of silk fibers that can be used to repair broken load-bearing bones without the complications sometimes presented by other materials.

Repairing major load-bearing bones such as those in the leg can be a long and uncomfortable process.

Im Focus: Writing and deleting magnets with lasers

Study published in the journal ACS Applied Materials & Interfaces is the outcome of an international effort that included teams from Dresden and Berlin in Germany, and the US.

Scientists at the Helmholtz-Zentrum Dresden-Rossendorf (HZDR) together with colleagues from the Helmholtz-Zentrum Berlin (HZB) and the University of Virginia...

Im Focus: Gamma-ray flashes from plasma filaments

Novel highly efficient and brilliant gamma-ray source: Based on model calculations, physicists of the Max PIanck Institute for Nuclear Physics in Heidelberg propose a novel method for an efficient high-brilliance gamma-ray source. A giant collimated gamma-ray pulse is generated from the interaction of a dense ultra-relativistic electron beam with a thin solid conductor. Energetic gamma-rays are copiously produced as the electron beam splits into filaments while propagating across the conductor. The resulting gamma-ray energy and flux enable novel experiments in nuclear and fundamental physics.

The typical wavelength of light interacting with an object of the microcosm scales with the size of this object. For atoms, this ranges from visible light to...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Invitation to the upcoming "Current Topics in Bioinformatics: Big Data in Genomics and Medicine"

13.04.2018 | Event News

Unique scope of UV LED technologies and applications presented in Berlin: ICULTA-2018

12.04.2018 | Event News

IWOLIA: A conference bringing together German Industrie 4.0 and French Industrie du Futur

09.04.2018 | Event News

 
Latest News

Quantum Technology for Advanced Imaging – QUILT

24.04.2018 | Information Technology

AWI researchers measure a record concentration of microplastic in arctic sea ice

24.04.2018 | Earth Sciences

Complete skin regeneration system of fish unraveled

24.04.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>