Powdered Chaste Tree Extract
» Powdered Chaste Tree Extract is prepared from Chaste Tree by extraction with hydroalcoholic mixtures or other suitable solvents. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of casticin and agnuside, calculated on the dried basis. It may contain suitable added substances.
Packaging and storage—
Preserve in tight containers, and store in a cool place, protected from light.
Labeling—
The label states the Latin binomial and, following the official name, the part of the plant from which the article was prepared. The label also indicates the content of casticin and agnuside, the extracting solvent or solvent mixture used for preparation, the ratio of the starting crude plant material to Powdered Extract, the percentage of native extract, and the name and quantity of any added substances. It meets the requirements for Labeling under Botanical Extracts 
565
.
565.
Identification—
A:
Thin-Layer Chromatographic Identification Test 201—
201—
Standard solution, Developing solvent system, and Procedure—
Proceed as directed for Identification test A under Chaste Tree.
Test solution—
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.
. 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.
Microbial enumeration 2021—
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.
2021—
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.
Loss on drying 731:
not more than 6.0%.
731:
not more than 6.0%.
Heavy metals, Method II 231:
not more than 20 µg per g.
231:
not more than 20 µg per g.
Content of casticin—
Solution A, Solution B, Standard solution, and Chromatographic system—
Proceed as directed under Chaste Tree.
Test solution—
Transfer an accurately weighed quantity of Extract equivalent to about 2.5 mg of the labeled content of casticin into a 50-mL volumetric flask. Add 25 mL of methanol, and sonicate in a bath at 40 for 10 minutes, shaking to disperse the solid. Cool to room temperature, dilute with methanol to volume, and mix. Centrifuge or pass through a filter having a 0.45-µm or finer porosity.
for 10 minutes, shaking to disperse the solid. Cool to room temperature, dilute with methanol to volume, and mix. Centrifuge or pass through a filter having a 0.45-µm or finer porosity.
Procedure—
Proceed as directed for Procedure under Chaste Tree. Calculate the percentage of casticin 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.
Content of agnuside—
Solvent, Solution A, Solution B, Standard solution, and Chromatographic system—
Proceed as directed under Chaste Tree.
Test solution—
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.
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—
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.
Other requirements—
It meets the requirements for Packaging and Storage, Residual Solvents, and Pesticide Residues under Botanical Extracts 565.
565.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Maged H. Sharaf, Ph.D.
Senior Scientist 1-301-816-8318 |
(DSB05) Dietary Supplements - Botanicals |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 2021 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 977
Pharmacopeial Forum: Volume No. 29(4) Page 1269