‘Unless otherwise stated, in a test or assay, the symmetry factor (tailing factor) of the peak used for quantitation is 0.8-1.8.’

When developing a monograph, the rapporteurs may notice that the default peak symmetry requirement (0.8-1.8) is not applicable, necessitating the provision of a specific requirement in the monograph. This approach has been followed by Ph. Eur. expert groups for decades and more than 100 monographs include a different minimum or maximum peak symmetry requirement.

This is further reinforced by the following sentence (see section System suitability): ‘When specific requirements are stated in the monograph, they supersede the requirements mentioned in this chapter.

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