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    Ginkgo leaf drugs and supplements testing

    Background

    From May 19th to 31st, 2015, CFDA investigated the pharmaceutical companies of ginkgo leaf medicine selling at low prices which are suspected to be illegal during the ginkgo leaf extraction process. The CFDA continuously formally announced notices and requested FDA branches and offices to carry out specific rectifications for Ginkgo medicine and supplements.

    Test products  
    Ginkgo leaf tablet, ginkgo leaf extract, ginkgo leaf capsule

    No.

    Items

    Method

    限量

    1

    Identification

    TLC

    -

    2

    Moisture

    Drying method***

    ≤5.0%

    3

    Residue on ignition

    ~

    ≤0.8%

    4

    heavy metals

    **

    ≤20mg/kg20 ppm

    5

    Total ginkgolic acid

    HPLC*

    ≤10mg/kg10ppm

    6

    Total flavonoids

    HPLC*

    ≥24%in dry base

    7

    Terpene lactones

    (bytotal of bilobalide, ginkgolide A, ginkgolide B and ginkgolide C)

    HPLC*

    ≥6.0%in dry base

    Chinese Pharmacopoeia=CP;*CP,Part 1 Appendix ⅨD; **CP, Part 1 Appendix ⅨE; ***CP, Part 1 AppendixⅨH; ~CP, Part 1 Appendix Ⅸ J;