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 90.0percent and not more than 110.0percent 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 Labelingunder Botanical Extracts á565ñ.
USP Reference standards á11ñ— USP Agnuside RS.USP Casticin RS.USP Powdered Chaste Tree Extract RS.
Change to read:
Identification—
A: Thin-layer chromatographic identification test á201ñ—
Standard solution,Developing solvent system,and Procedure— Proceed as directed for Identification test Aunder Chaste Tree.
Test solution— Shake a quantity of Extract equivalent to 10mg of the labeled amount of agnuside in 10mLof methanol,and heat in a water bath at 60.Centrifuge or filter before use.
B:USP28 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:USP28 The chromatogram of the Test solutionobtained as directed in the test for Content of agnuside,exhibits a peak at the retention time corresponding to agnuside.
Loss on drying á731ñ: not more than 6.0%.
Heavy metals,Method IIá231ñ: not more than 20µg per g.
Microbial enumeration á2021ñ— The total bacterial count does not exceed 104cfu per g.The total combined molds and yeasts count does not exceed 1000cfu per g.It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
Content of casticin—
Solution A,Solution B,Standard solution,andChromatographic system— Proceed as directed under Chaste Tree.
Test solution— Transfer an accurately weighed quantity of Extract equivalent to about 2.5mg of the labeled content of casticin into a 50-mLvolumetric flask.Add 25mLof methanol,and sonicate in a bath at 40for 10minutes,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 Procedureunder 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 6.25mg of the labeled content of agnuside into a 50-mLvolumetric flask.Add about 25mLof Solvent,and sonicate in a bath at 40for 10minutes,shaking to disperse the solid.Cool to room temperature,dilute with Solventto volume,and mix.Centrifuge or pass through a filter having a 0.45-µm or finer porosity.
Procedure— Proceed as directed for Procedureunder 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 Residuesunder Botanical Extracts á565ñ.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2065
Pharmacopeial Forum:Volume No.29(4)Page 1269
Phone Number:1-301-816-8343