Candidates for 2016 ERP of the Year

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)

UMMARY OF

ETHOD

ENERAL

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.

ROS

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.

ONS

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

ERP PROFILE SUMMARIES