Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-06

SJW-06:

St. John’s wort - Hypericiherba

EUROPEAN PHARMACOPOEIA 6.0 (pp 2958-2959)

Author(s):

S UMMARY OF M ETHOD : G ENERAL C OMMENTS :

This method is spectrophotometric quantitation of hypericins for regulatory compliance of St. John’s wort raw material in the European Union. Quantitation of the sum of hypericin, pseudohypericin, protohypericin and protopseudohypericin calculated as total napthodianthrones expressed as “hypericin” for crude herbal St. John’s wort material. P ROS /S TRENGTHS : Based on historical use of this method and its widespread utility by industry in the US and EU, this is a rapid and effective screening tool for basic quality assessment of St. John’s wort raw material that meets the identification requirements of the European Pharmacopoeia. It has been officially accepted in formal compendium since at least 1991 and continues to be the officially accepted screening method for St. John’s wort raw material. Once identification has been appropriately established, this method is a robust tool for the basic quality analysis of St. John’s wort raw material. C ONS /W EAKNESSES : For the analytical endpoint of quantifying total napthodianthrones inappropriately identified material this method is well suited with no deficiencies of which I am aware. Some may state that UV will not detect the presence of dyes that are viewed in the same wavelength and therefore cannot detect adulterants, but the stated purpose is for quantitation of material that has been appropriately identified. Does not quantify flavonoids and hyperforin as desired by AOAC.

EXPERT REVIEW PANEL VOTE AND RECOMMENDATION

MOTION: Not to consider this method for First Action Official Method status. Brown, Sharaf (Unanimous) Motion Passed

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