q&more
My watch list
my.chemie.de  
Login  

White papers

Weighing in compliance with European Pharmacopoeia

Weighing requirements according to the Ph. Eur. 2.1.7 “Balances for analytical purposes”

Weighing according to Ph. Eur. – Ensuring compliance with Chapter 2.1.7

The new European Pharmacopoeia (Ph. Eur.) General Chapter 2.1.7 “Balances for Analytical Purposes” is a mandatory requirement for the quality control of medicines in European member states, or for any pharmaceutical company who exports into the European market. It has a similar legal status to the USP compendium in the United States. Ph. Eur. 2.1.7 requirements describe the same tests and criteria as USP General Chapter 41, but Ph. Eur. explicitly states that calibration should include measurement uncertainty and emphasizes the concept of as found and as left calibration.

This white paper describes the weighing requirements according to the European Pharmacopoeia General Chapter 2.1.7 “Balances for analytical purposes”. Compliance with calibration, performance checks and the life-cycle management defined within this chapter is mandatory when working according Ph. Eur. monographs.

Facts, background information, dossiers

  • analysis
  • quality management system
  • European Pharmacopoeia
  • weighing requirements
  • weighing procedure
  • standard preparations
  • testing of drug substances
  • testing of dosage forms
  • HPLC analysis

More about Mettler-Toledo

q&more – the networking platform for quality excellence in lab and process

The q&more concept is to increase the visibility of recent research and innovative solutions, and support the exchange of knowledge. In the broad spectrum of subjects covered, the focus is on achieving maximum quality in highly innovative sectors. As a modern knowledge platform, q&more offers market participants one-of-a-kind networking opportunities. Cutting-edge research is presented by authors of international repute. Attractively presented in a high-quality context, and published in German and English, the original articles introduce new concepts and highlight unconventional solution strategies.

> more about q&more

q&more is supported by:

 

Your browser is not current. Microsoft Internet Explorer 6.0 does not support some functions on Chemie.DE