Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-07

SJW-07:

St. John’s wort Dry Extract, Quantified Hyperici herbae extractumsiccum quantificatum

Author(s):

EUROPEAN PHARMACOPOEIA 7.6 (pp 4878-4880)

S UMMARY OF M ETHOD : G ENERAL C OMMENTS :

Two methods are included in the monograph. The first is used for the quantification, after light conversion, of total hypericins (pseudohypericin and hypericin) expressed as hypericin. The second method is used for the quantification of hyperforin, using a provided correction factor, and flavonoids, all expressed as rutin. P ROS /S TRENGTHS : This method allows for the quantification of the various components of interest and marker components in St. John’s wort. The methods are specific and stability-indicating compared to spectrometry methods.The methods provide a complementary tool for the article identification along with the TLC test included in the monograph. The methods include the use of quantitative and qualitative reference standards.The methods employ materials and chemicals that are readily available. The strength of the methods is that they are purported to run all analytes of interest to AOAC and that they represent the methods required for regulatory compliance in the EU. The LC method for hypericins appears sound and uses a St. John’s wort dry extract as a reference standard, rather than the relatively unstable hypericin reference materials. C ONS /W EAKNESSES : Users will need to do two set up and prepare materials for two methods.Information is not provided concerning the applicability of the methods to St. John’s wort plant material; forms, preparations and products other than the extracts subject of the monograph; and to other Hypericum spp. The EP monograph for St. John’s wort plant material includes a spectrometry method for the content of hypericins. Supporting data required to ensure method performance requirements are not provided.

EXPERT REVIEW PANEL VOTE AND RECOMMENDATION

MOTION: Not to make a decision on this method at this time pending receipt and review of validation data. Sharaf, Brown (Unanimous) Motion Passed

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