Candidates for 2016 ERP of the Year

Primary and Secondary Evaluation of Method SJW-09

SJW-09:

St. John’s wort

Author(s):

USP 36 (pp 1579-1581)

UMMARY OF

ETHOD

ENERAL

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.

ROS

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.

ONS

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

ERP PROFILE SUMMARIES