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  • Certificate Of Analysis: Sun Teh Pma麗Mceotical Co.#

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    R Bunardi
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    This certificate of analysis summarizes the test results for a batch of Chuan Xiong powder (Rhizoma Chuanxiong). The powder met all specifications for identification, purity, heavy metals, weight variation, and microbiological limits. Tests showed the powder had less than the limit for loss on drying, total ash, acid-insoluble ash, and met limits for water and dilute-alcohol extractives. Microbial testing was below limits for total aerobic count, yeasts and molds, bile-tolerant gram-negative bacteria, E. coli, and Salmonella. The batch was deemed to have passed all tests.

    Descrizione originale:

    TCM

    Titolo originale

    川芎 Chuan Xiong-14050204

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    This certificate of analysis summarizes the test results for a batch of Chuan Xiong powder (Rhizoma Chuanxiong). The powder met all specifications for identification, purity, heavy metals, weight variation, and microbiological limits. Tests showed the powder had less than the limit for loss on drying, total ash, acid-insoluble ash, and met limits for water and dilute-alcohol extractives. Microbial testing was below limits for total aerobic count, yeasts and molds, bile-tolerant gram-negative bacteria, E. coli, and Salmonella. The batch was deemed to have passed all tests.

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    © All Rights Reserved
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    33 visualizzazioni2 pagine

    Certificate Of Analysis: Sun Teh Pma麗Mceotical Co.#

    Caricato da

    R Bunardi
    This certificate of analysis summarizes the test results for a batch of Chuan Xiong powder (Rhizoma Chuanxiong). The powder met all specifications for identification, purity, heavy metals, weight variation, and microbiological limits. Tests showed the powder had less than the limit for loss on drying, total ash, acid-insoluble ash, and met limits for water and dilute-alcohol extractives. Microbial testing was below limits for total aerobic count, yeasts and molds, bile-tolerant gram-negative bacteria, E. coli, and Salmonella. The batch was deemed to have passed all tests.

    Copyright:

    © All Rights Reserved
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    di 2

    SUN TEH PMAmCEOTICAL CO.

    # %TB,
    3F, No. 207
    Sec. 3Beixin Rd., Xindian Dist., New Taipei City 23143Taiwan
    TEL: 886-2-8978-5799 FAX: 886-2-8913-1676
    http://www.suntenglobal.com

    Certificate of Analysis
    Product Code ()5305
    Pin Yin Name () :Chuan Xiong
    Chinese Product Name ( ) : ) 11
    Pharmaceutical Name ()Rhizoma Chuanxiong
    Dosage Form ()
    Powders
    Batch No.()14050204
    Items
    1. General Description

    2. Loss on Drying

    3. Total Ash

    4. Acid-Insoluble Ash

    5. Water Extractive

    6. Dilute-Alcohol Extractive

    7. TLC Identification
    -TLC
    Rhizoma Chuanxiong

    Specifications
    Brown powder with specific and rich aroma and pungent
    and bitter taste.

    Results
    Conformed

    Less than 9.00%

    3.44%

    Less than 7.00%

    2.83%

    Less than 4.00%

    0.50%

    More than 25.00%

    55.53%

    More than 23.00%

    50.44%

    The reference standard solution and the sample solution


    each has a bluish white fluorescent spot at Rf=0.74.

    Positive

    8. Heavy Metals

    As (ppm)
    Cd (ppm)
    Hg (ppm)
    Pb (ppm)
    9. Weight Variation

    ()
    10. Average Weight

    ()

    Less than 2 ppm


    Less than 1.0 ppm
    Less than 0.1 ppm
    Less than 5 ppm

    0.154 ppm
    0.239 ppm
    0.009 ppm
    0.809 ppm

    Net weight should not be less than the labeled weight.

    Conformed

    The average weight should not be less than the labeled


    weight.

    Conformed

    Version No: UK1 P 2

    Smn TEM FHAKMAC EUTICAL CO., OT>.

    3F
    No. 207
    Sec. 3
    Beixin Rd., Xindian Dist., New Taipei City 23143?Taiwan
    TEL: 886-2-8978-5799 FAX: 886-2-8913-1676
    http://www.suntenglobal.com

    Certificate of Analysis
    Product Code ()
    5305
    Pin Yin Name () :Chuan Xiong
    Chinese Product Name () : j f1
    Pharmaceutical Name () :Rhizoma Chuanxiong
    Dosage Form ():Powders
    Batch No.()14050204
    Items
    11. Microbial Tests;

    TAMC

    TYMC

    Bile-tolerant G(-) bacteria

    E. Coli

    Salmonella

    Specifications

    Results

    Ph. Eur. 5.1.8


    Less than 5 x 104CFU/g

    180 CFU/g

    Less than 5 x 102CFU/g

    <10 CFU/g

    Less than 102 CFU/g

    <10 CFU/g

    Nil in 1 g

    Nil

    Nil in 25 g

    Nil

    TAMC:Total aerobic microbial count


    TYMC:Total combined yeasts/moulds count

    ConclusioniPassed

    Authorized by: _________ _____________


    Huang, Li Wei
    Chief of QA

    Date: 31 / Jul / 14

    Version No: UK1 P 2

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