Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-12

SJW-12:

Determination of naphthodiantrones in St. John’s wort extracts and herbal drugs (SOP No. DC-185)

Euromed USA

Author(s):

S UMMARY OF M ETHOD : G ENERAL C OMMENTS :

This is a spectrophotometric method for the determination of hypericins in St. John's wort extracts and herbal plant preparations. The method concerns qualitative determination of hypericins through spectrometry analysis at 590 nm. Extraction method is straight forward and allows for exposure time under white light prior to analysis. White light is used to ensure conversion to protohypericin to hypericin. A blank is always run with each sample and samples are prepared in duplicate. Although the method is simple and straight forward, it only looks at the total hypericins without actual separation of the individual compounds. As this is a nonspecific method, it would not give good information on the individual compounds for use in a clinical research program. It would be beneficial possibly in a QC program internally of raw material verification.

P ROS /S TRENGTHS : This method is simple and easy to follow and is good for internal quality controls.

C ONS /W EAKNESSES : The use of hypericin specific absorption which could vary according to the operating conditions.The presence of other compounds absorbing in the used 590 nm range could conduct to erroneous results. As a nonspecific method, it does not quantify for the individual hypericin compounds. As 590nm is based on color analysis, the method would unlikely detect adulteration.

EXPERT REVIEW PANEL VOTE AND RECOMMENDATION

MOTION: Not to consider this method for First Action Official Method status. Es-Safi, Schaneberg (Unanimous) Motion Passed

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