Test agnuside  in the Chaste Tree Extract

Chaste Tree Extract is prepared from Chaste Tree by extraction with hydroalcoholic mixtures solvents.

 Packaging and storage¡ª Preserve in tight containers, and store in a cool place, protected from light.

Identification¡ª

A: Thin-layer chromatographic identification test 201 ¡ª

Standard solution, Developing solvent system, and Procedure¡ª Proceed as directed for Identification test A under Chaste Tree.

Test solution¡ª Shake a quantity of Extract equivalent to 10 mg of the labeled amount of agnuside in 10 mL of methanol, and heat in a water bath at 60 . Centrifuge or filter before use.

B: The chromatogram of the Test solution, obtained as directed in the test for Content of casticin, exhibits a peak at the retention time corresponding to casticin.

C: The chromatogram of the Test solution obtained as directed in the test for Content of agnuside, exhibits a peak at the retention time corresponding to agnuside.

Loss on drying 731 : not more than 5.0%.

Heavy metals, Method II 231 : not more than 20 µg per g.

Organic volatile impurities, Method VI 467 : meets the requirements.

Microbial enumeration 2021 ¡ª The total bacterial count does not exceed 104 cfu per g. The total combined molds and yeasts count does not exceed 1000 cfu per g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.

 

Content of agnuside¡ª

Solvent, Solution A, Solution B, Standard solution, and Chromatographic system¡ª Proceed as directed under Chaste Tree.

Test solution¡ª Transfer an accurately weighed amount of Extract equivalent to about 6.25 mg of the labeled content of agnuside into a 50-mL volumetric flask. Add about 25 mL of Solvent, and sonicate in a bath at 40 for 10 minutes, shaking to disperse the solid. Cool to room temperature, dilute with Solvent to volume, and mix. Centrifuge or pass through a filter having a 0.45-µm or finer porosity.

Procedure¡ª Proceed as directed for Procedure under Chaste Tree. Calculate the percentage of agnuside in the portion of Powdered Chaste Tree Extract taken by the formula:

5000(C/W )(rU / rS),

in which the terms are as defined therein.

Residual solvents 467 : meets the requirements.

(Official January 1, 2007)

                                          Hangzhou Greensky Biological Tech.Co.,Ltd