Answer:

A certificate of suitability (CEP) does not replace a certificate of analysis and does not guarantee that a batch of the substance is of suitable quality. It is also not a replacement for a GMP certificate. A CEP demonstrates that the given substance is suitably controlled by the Ph. Eur. monograph with additions if necessary.

For more information, see How to read a CEP (PA/PH/CEP (15) 31).

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