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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.
- 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.
- Introduce a suitable control in their specification which is capable of controlling the degree of hydration claimed.
- 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.