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Primary and Secondary Evaluation of Method SJW-13

SJW-13:

Determination of hyperforin in St. John’s wort extracts and herbal drugs (SOP No.

HPLC-352)

Author(s):

Euromed USA

S

UMMARY OF

M

ETHOD

:

G

ENERAL

C

OMMENTS

:

Method review forms were not received for this method due to the absence of the reviewers. However,

the Expert Review Panel discussed this method during the meeting and requested further information

and validation data for this method.

P

ROS

/S

TRENGTHS

:

N/A

C

ONS

/W

EAKNESSES

:

N/A

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.

Brown, Mudge (Unanimous) Motion Passed

ERP PROFILE SUMMARIES

95