川芎 chuan xiong-14050204

2
顺天奎藥廒股份有隈公萄 SUN TEH PMA mCEOTICAL CO.# %TB, 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 ( ):) 11 Pharmaceutical Name ( ) Rhizoma Chuanxiong Dosage Form ( ) Powders Batch No.( ) 14050204 Items Specifications Results 1. General Description Brown powder with specific and rich aroma and pungent and bitter taste. Conformed 2. Loss on Drying Less than 9.00% 3.44% 3. Total Ash Less than 7.00% 2.83% 4. Acid-Insoluble Ash Less than 4.00% 0.50% 5. Water Extractive More than 25.00% 55.53% 6. Dilute-Alcohol Extractive More than 23.00% 50.44% 7. TLC Identification -TLC Rhizoma Chuanxiong 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) 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 9. Weight Variation ( ) Net weight should not be less than the labeled weight. Conformed 10. Average Weight ( ) The average weight should not be less than the labeled weight. Conformed Version No: UK1 P 2

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Page 1: 川芎 Chuan Xiong-14050204

赢 顺 天 奎 藥 廒 股 份 有 隈 公 萄SUN TEH PMA麗mCEOTICAL CO.# %TB,

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 (品號):5305

Pin Yin Name (拼音名) :Chuan Xiong

Chinese Product Name (中文品名) : )11尊濃縮散Pharmaceutical Name (學名):Rhizoma Chuanxiong

Dosage Form (劑型):Powders

Batch No.(批號):14050204

Items Specifications Results

1. General Description

件狀

Brown powder with specific and rich aroma and pungent

and bitter taste.Conformed

2. Loss on Drying

乾燥減重Less than 9.00% 3.44%

3. Total Ash

總灰分Less than 7.00% 2.83%

4. Acid-Insoluble Ash

酸不溶性灰分Less than 4.00% 0.50%

5. Water Extractive

水抽提物More than 25.00% 55.53%

6. Dilute-Alcohol Extractive

稀醇抽提物More than 23.00% 50.44%

7. TLC Identification

鑑別-TLC Rhizoma Chuanxiong

川芎

The reference standard solution and the sample solution

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

8. Heavy Metals

分項重金屬試驗 As 砷 (ppm)

Cd 鎘 (ppm)

Hg 永 (ppm)

Pb 錯 (ppm)

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

9. Weight Variation

重(容)量差異試驗Net weight should not be less than the labeled weight. Conformed

10. Average Weight

平均重(容)量

The average weight should not be less than the labeled

weight.Conformed

Version No: UK1 P 2

Page 2: 川芎 Chuan Xiong-14050204

A 順夭豐藥廠股份有限秦爾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 (品號):5305

Pin Yin Name (拼音名) :Chuan Xiong

Chinese Product Name (中文品名) : j f 1号濃縮散Pharmaceutical Name (學名):Rhizoma Chuanxiong

Dosage Form (劑型):Powders

Batch No.(批號):14050204

Items Specifications Results11. Microbial Tests;

微生物試驗 TAMC

好氧菌總數 TYMC

酵母菌及黴菌總數 Bile-tolerant G(-) bacteria

膽汁耐受革蘭氏陰性菌 E. Coli

大腸桿菌 Salmonella

沙門氏菌

Ph. Eur. 5.1.8

Less than 5 x 104 CFU/g

Less than 5 x 102 CFU/g

Less than 102 CFU/g

Nil in 1 g

Nil in 25 g

180 CFU/g

<10 CFU/g

<10 CFU/g

Nil

Nil

TAMC:Total aerobic microbial count

TYMC:Total combined yeasts/moulds count

ConclusioniPassed

Authorized by: _________ _____________ Date: 31 / Jul / 14

Huang, Li Wei

Chief of QA

2 Version No: UK1 P 2