Short Description:

Gentian Root Extract Powder is a kind of Chinese traditional herbal medicine.It is mainly distributed in northern of China.Gentian Root Extract Powder is coming from gentian scabra root and rhizomes.This powder is an excellent bitter and cold nature.

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Quality Standand


Product Name: Genistein

Latin name:Genista tinctoria Linn.

Quality standard: National Standard

Specification: 98%

Test method:HPLC

CAS NO: 446-72-0

Appearance: Off- White powder

Storage method:  Store in cool and dry place. Keep away from strong light and heat.

Shelf life: 24 month

Source of extraction: Soybeans/Sophora japonica

Package specification: 1kg / aluminum foil bag, 25kg/Drum or as required by customers

Product introduction: Genistein is slightly soluble in water

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  • Quality standards of Gentianae Radix Et Rhizoma Extract

    Shannxi Green Bio-Engineering co.,ltd

    Oct 1st.2017 implemented


    This standard is drafted according to the rules given in GB/T1.1-2009.

    The issuing body of this standard shall not be responsible for the identification of any patents that may be involved in the content of this standard.

    Appendix a of this standard is normative appendix.

    This standard is drafted by Shaanxi Green Bio-Engineering Co. , Ltd. .

    Main drafters of this standard: Wen Zhou, Liu Tao.

    Gentian extract

     1 scope of this technical requirement, specifies, the technical requirements, test methods, test rules and labels of Gentian extract of dietary supplement material. The requirements of this standard apply to Gentian medicine as raw material processed into the extract.

    2 normative reference document the terms in the following documents become the terms of this technical requirement by reference to this technical requirement. All subsequent amendments (excluding errata) or revisions to the reference document of the date are not applicable to this technical requirement. However, parties that have reached an agreement pursuant to this technical requirement are encouraged to explore the possibility of using the latest version of these documents. The latest version of any undated reference file is applicable to this technical requirement. Determination of total arsenic and inorganic arsenic in food

    GB/t 5009.12 determination of lead in food

    GB/t 5009.15 determination of cadmium in food

    GB/t 5009.17 determination of total mercury and organic mercury in food

    GB/t 5009.19 determination of multi-component residues of organochlorine pesticides in food

    GB 4789.2 food safety, determination of total bacterial count

    GB 4789.3 food safety, coliform bacteria

    GB 4789.15 food safety, mould and Yeast Count, Pharmacopoeia of the People’s Republic of China 2015,4

    Parts 3 Gentiopicroside, molecular formula C16H20O9, molecular weight 356.32, structural formula as follows

    4 technical requirements

    4.1 technical requirements

    4.1.1 dry roots and rhizomes of Gentiana Scabra Bunge.

     4.1.2 plant materials, harvested in spring and autumn to remove impurities and dry.

    4.1.3 process, alcohol extraction, concentration, drying.

     4.2 sensory requirements shall be in accordance with table 1 requirements

    table 1 sensory indicators





    taste and smell

    with gentian-specific odor


    dry  powder


    no foreign impurities visible to the naked eye


    4.3  iconic ingredients shall meet the requirements of Table 2 iconic ingredient items and indicators of Table 2



    The content of Gentiopicroside (G/100G)

     More than or equal to 10.0

    4.4. The physical and chemical requirements should meet the physical and chemical requirements of Table 3



    Particle size [80 mesh sieve pass rate (%)]    ≧


    water regime(%)                 ≦


    Ash on dry(%)                    ≦


    As/(As, mg/kg)        ≦


    PB/(PB, mg/kg)   ≦


    Cd/(mg/kg, CD)       ≦


    Mercury/(Hg, mg/kg)        ≦


    hexachlorocyclohexane(mg/kg)              ≦


    DDT(mg/kg)              ≦


    Pentachloronitrobenzene(mg/kg)          ≦


    4.5 Microbiological Indicators shall meet the requirements of Table 4



    Total Plate Count /(cfu/g)           ≦


    Yeast & Mold /(cfu/g)       ≦








    5 test method

     5.1 smell and test  the sample immediately after opening the sample, put some of the sample in the white porcelain plate to observe its color, appearance and check whether there is any foreign matter.

    5.2 physical and chemical requirements

    5.2.1 gentiopicroside content, determination of Appendix A

    5.2.2 granularity in accordance with appendix a method, according to the screening method prescribed in the fourth general rule 0982(second method) of the 2015 edition of the Pharmacopoeia of the People’s Republic of China.

    5.2.3 moisture is determined in accordance with the method specified in the fourth general rule 0832(second law) of the Pharmacopoeia of the People’s Republic of China 2015 edition.

    5.2.4 ash is determined in accordance with the method specified in general rule 1106 of the Pharmacopoeia of the People’s Republic of China, 2015 edition.

     5.2.5 arsenic-determination of total arsenic and inorganic arsenic in food by GB/t 5009.11.

    5.2.6 lead is determined by the method for the determination of lead in foods GB/t 5009.12.

    5.2.7 cadmium — determination of cadmium in food by GB/t 5009.15.

    5.2.8 determination of total mercury and inorganic mercury in foods by GB/t 5009.17. 5.2.9 BHC, DDT and PCNB shall be implemented in accordance with GB/t 5009.19. 5.4 Microbiological Examination

    5.4.1 total colony count was carried out in accordance with national food hygiene standard GB4789.2.

    5.4.2 mould and yeast were carried out in accordance with national food hygiene standard GB4789.15.

     5.4.3 coliform bacteria were collected in accordance with national food hygiene standard GB4789.3.

    5.4.4 Salmonella was carried out according to the national food hygiene standard GB4789.4.

    5.4.5 STAPHYLOCOCCI were carried out according to the national food hygiene standard GB4789.10.

    6 Inspection rule

    6.1 the batch inspection shall be sampled in accordance with the method prescribed in general rule 0211 of the Pharmacopoeia of the People’s Republic of China, 2015 edition, the same batch of products with uniform mixture and the same quality in a certain extent were tested.

    6.2 Inspection Classification

    6.2.1 ex-factory inspection products shall be inspected in batches according to the requirements of 4.2 ~ 4.5 by the Quality Inspection Department of the factory before they leave the factory. Products that have passed the inspection and have been issued with certificates of quality before they leave the factory for sale. 6.2.2 type checking in accordance with Chapter 4.

    Type Inspection shall be conducted every six months under any of the following circumstances, should also be carried out: A) when there is a major change in raw materials; b) when the key process is adjusted; c) when the equipment is replaced or stopped and production resumes; d) when there is a major difference between the results of the ex-factory inspection and the last type inspection. 6.3 Decision rule

    6.3.1 when one of the test results does not meet the technical requirements, a double sample of the same batch of products shall be re-selected at random for re-examination, and the re-examination result shall prevail. If the reinspection still has an index unqualified, the batch of products will be judged to be unqualified.

    6.3.2 if any item of the microbiology project fails to meet the technical requirements, it shall be deemed to be unqualified and shall not be re-examined.

    6.3.3 judgment of type inspection and ex-factory inspection.

    7 Label, packaging, transportation, storage

    7.1 label

     7.1.1 on the package label should be marked: sample name, production date, production lot number, specification, gross weight, net weight, implementation standard.

    7.1.2 the content of the label is clearly visible and the label is securely affixed.

     7.2 Packaging, packaging materials shall comply with food safety requirements. Before use, the packaging material used should be subjected to strict sanitary inspection. Sealed and sealed after packing in drums.

    7.3 Transportation

    7.3.1 the means of transport shall be clean and hygienic and shall not be mixed with toxic, harmful, corrosive or smelly articles.

    7.3.2 handling should be light loading and unloading, transportation to prevent extrusion, exposure, rain.

    7.4 storage

    7.4.1 products shall not be mixed with toxic, harmful, corrosive or odorous substances.

    7.4.2 the product should be sealed and stored in a cool, dry place. 7.5 shelf life of 24 months.

    Appendix A

    Determination of Gentiopicroside

    A. 1 method abstract after ultrasonic extraction of samples, the use of High-performance liquid chromatography detection.

     A. 2 test instruments and apparatus

    A. 2.1 analytical balance, accuracy one part per million

    A. 2.2 ultrasonic cleaner: 250 W, 20 Khza.

    2.3 High-performance Liquid Chromatography

     A.3.1 methanol, analytical pure,

    A. 3.2 water, iI distilled water

     A. 3.3 gentiopicroside reference

    A. 3.4 flow matching: According to the methanol-water (25:75) ratio mixed preparation, micro-porous membrane filtration.

    A. 3.5 detector and detection wavelength: Ultraviolet spectrophotometer, detection wavelength 270 nm.

    A. 4 Method

    A. 4.1 preparation of reference solution: precise weighing gentiopicroside reference solution (accurate to 0.01 MG) , add methanol to make a solution containing 40 g per 1 ml, as the reference solution.

    A. 4.2 preparation of test solution: Take Gentian extract sample about 30 mg, precision weighing, add methanol ultrasonic dissolve, methanol constant volume, as test solution.

    A. 4.3 the method is determined by injection of 10 l of the control solution and 10 l of the test solution into a liquid chromatograph.

    A. 5 the result calculated the content of gentiside according to formula (B. 1) :

    gentiside (%) = … …… .. (B. 1)


     S1-solution peak area value;

    s0-solution peak area value;

    c-control solution concentration (mg/ml) ;

    a-control content (%) ;

    b-sample moisture content (%) ;

    m-sample solution concentration (MG/ML) .


    Assay by High-performance Liquid Chromatography (appendix VI D to the Pharmacopoeia of the People’s Republic of China 2010 edition). CHROMATOGRAPHIC conditions and system suitability tests were carried out with octadecyl Silane Bonded Silica Gel as packing agent, methanol-water (25:75) as mobile phase and detection wavelength at 270nm. The theoretical plate number should not be less than 3000 according to gentiopicroside peak. The preparation of the control solution, gentiopicroside control of the right amount, precision, add methanol made of 0.2 mg/l of the solution, that is. Preparation of the sample solution, take this powder (through the fourth sieve) about 0.5 g, precision weighing, precision adding methanol 20ml, weighing the weight, heating reflux for 15 minutes, cool, then weighing the weight, with methanol to make up the lost weight, shake, filter, filtrate reserve, precision volume of continuous filtrate 2ml, placed in a 10ML bottle, add methanol to scale, shake well, get. The method was determined by HPLC with 10 l of the control solution and 10 l of the test solution. This product according to dry goods calculation, Gentiana gentiopicroside (C 16 H 209) shall not be less than 3. 0% ; gentiopicroside (C1S H 2O s) in Gentiana scabra should not be less than 1.5%


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