Is it possible to apply for a Chemical CEP with reference to a specific polymorphic form when no statement on polymorphism is included in the corresponding individual Ph. Eur. monograph?

Answer:

It is possible to apply for a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) for a specific polymorphic form (as a grade) even if the statement “the substance shows polymorphism” is not mentioned in the “Characters” section of the corresponding individual Ph. Eur. monograph.

In such cases, the specifications for the substance should include a suitable analytical procedure for characterising the specific polymorph and the applicant should demonstrate that the substance shows polymorphism by providing data from the literature or any other appropriate evidence.

If the application is accepted, a subtitle for the specific polymorph will be mentioned on the CEP and the procedure used to characterise the polymorph will be appended to it.