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
.
Identification—
A:
Thin-layer chromatographic identification test 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.
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 10
4 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 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.
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.
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.
Auxiliary Information—
Staff Liaison :
Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 2303
Pharmacopeial Forum : Volume No. 29(4) Page 1269
Phone Number : 1-301-816-8318
