(NEW 17/07/2024) In our CEP application, is it possible to claim that the quality of our substance complies with a specific degree of hydration when degree of hydration is not defined in the corresponding individual Ph. Eur. monograph?

Answer:

If the Ph. Eur. monograph foresees a specific degree of hydration (definition section and/or title) then the quality of the substance must be in compliance with this, and no other degree(s) of hydration can be claimed in the context of a certificate of suitability (CEP).

If the Ph. Eur. monograph does not foresee any specific degree(s) of hydration (definition section and/or title) then based on the quality of their substance an applicant for a certificate of suitability may wish to submit a dossier for a specific degree of hydration (as a grade) on the provision that in their application, they.

1. Can suitably justify that the requested degree of hydration is possible (from the literature or any other appropriate evidence) and that it is suitably produced.
2. Introduce a suitable control in their specification which is capable of controlling the degree of hydration claimed.
3. Are in compliance with the limit(s) for the control of water as described in the Ph. Eur. monograph (e.g. water content, loss on drying).

If the application is accepted, a subtitle for the degree of hydration would be mentioned on the CEP when granted and the analytical procedure used to control this appended.