Abstract
Although the water conductivity monographs of Ph. Eur. and USP have been in place for several years, there is still considerable confusion within the pharmaceutical industry on their interpretation and implementation. This paper gives a detailed interpretation of these regulations, including official clarification of the Ph. Eur conductivity monograph that these authors have received from the European Directorate for the Quality of Medicines. As well as covering the measuring equipment and test methodology required for compliance, this paper also explains why the use of low-level, aqueous conductivity standards is essential for regulatory compliance.
Contents of the Paper
- Introduction
- Pharmacopoeial Requirements
- Complying with the Pharmacopoeias
- Full Audit-Compliance of Conductivity Measurements
- Recommended Improvements to the Monographs
- Conclusion
- References