Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-09

SJW-09:

St. John’s wort

USP 36 (pp 1579-1581)

Author(s):

S UMMARY OF M ETHOD : G ENERAL C OMMENTS :

One RP LC method is included in the monograph for the quantification of the content of hypericin and pseudohypericin and hyperforin. Protection from light is recommended. A surrogate reference standard is used for quantitative purposes and correction factors are provided. Another extract reference standard is used for qualitative purposes and to establish system suitability. P ROS /S TRENGTHS : The method makes it possible the quantification of some of the components of interest and marker components of in St. John’s wort. The method is specific and stability-indicating compared to spectrometry methods.The method provides a complementary tool for the article identification along with the TLC test included in themonograph. The method includes the use of quantitative and qualitative reference standards. The method employs materials and chemicals that are readily available. The same method is used for the plant materials. C ONS /W EAKNESSES : Information is not provided concerning the applicability of the method to St. John’s wort products and other Hypericum spp. No information was provided concerning the applicability of the method for the quantification of the flavonoids content. Only hyperforin is quantified. 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, Schaneberg (Unanimous) Motion Passed

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