The analytical procedures chosen for the identification tests, purity tests and assay(s) constituting the bulk of a pharmacopoeial monograph are preferably those already described and utilised in the Ph. Eur. In this context, the author of a monograph is referred not only to the General Chapters of the Ph. Eur. but also to published monographs on similar materials. The above considerations are intended to ensure a reasonable degree of harmonisation within the Ph. Eur. and only apply in cases where the procedures are found to be adequate for the specific purposes. However, due attention is also to be paid to the development of new procedures that offer significant improvements in terms of sensitivity, precision, accuracy or specificity/selectivity.
Analytical procedures included in monographs are validated as described in part III (ANALYTICAL VALIDATION) and other relevant specific parts of this guide. Validation reports are provided to the EDQM but are not published or otherwise provided to users.
The analytical procedures included in a monograph are validated and further verified in two or more laboratories. One of these may be the supplier of the procedure who initially validated it.
The laboratory reports on the validation and verification are to be provided to the EDQM to ensure future traceability.
The instructions for any analytical procedure cover all factors that may influence the results and that are deemed essential for an experienced analyst working according to acknowledged laboratory practices to be able to perform the analysis without necessarily having any prior knowledge of the investigation in question. Variations in the description of similar analytical procedures are to be avoided
If it is expected that an analytical procedure will be used generally or if it requires a lengthy description and is used more than once, it may be proposed for inclusion in the general chapters of the Ph. Eur., to be referred to in the individual monographs. The procedures are prescribed on the scale conventionally applied in the Ph. Eur. except in cases where for reasons of availability of the material to be analysed, or because of its toxicity or its cost, work on a small scale would be advantageous.