Black Cohosh Fluidextract
» Black Cohosh Fluidextract is prepared from Black Cohosh by extraction with hydroalcoholic mixtures or isopropanol–water mixtures. Each mL contains the extracted constituents of 1 g of the plant material. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of triterpene glycosides, calculated as 23-epi-26-deoxyactein (C37H56O10).
Packaging and storage— Preserve in tight, light-resistant containers, and store in a cool place.
Labeling— It meets the requirements for Labeling under Botanical Extracts 565. Label it to indicate the content, in percentage, of triterpene glycosides, calculated as 23-epi-26-deoxyactein. Dosage forms prepared with this article should bear the following statement: Discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice.
Identification—
A: Thin-Layer Chromatographic Identification Test 201—
Test solution— Use the Fluidextract.
Standard solution 1, Standard solution 2, Developing solvent system, Spray reagent, and Procedure— Proceed as directed for Identification test A under Black Cohosh.
B: Thin-Layer Chromatographic Identification Test 201—
Test solution— Use the Fluidextract, diluting if necessary with a suitable solvent to obtain a solution containing about 0.25 mg per mL of triterpene glycosides.
Standard solution 1, Standard solution 2, Developing solvent system, Spray reagent, and Procedure— Proceed as directed for Identification test B under Black Cohosh.
C: The chromatogram of the Test solution exhibits peaks for cimiracemoside A, 26-deoxycimicifugoside, (26S)-actein, 23-epi-26-deoxyactein, cimigenol-arabinoside, and cimigenol-xyloside at retention times corresponding to those compounds in the chromatogram of the Standard solution, as obtained in the test for Content of triterpene glycosides. The ratio of the peak areas of cimigenol-arabinoside to cimigenol-xyloside is not less than 0.4 (distinction from Cimicifuga foetida).
Microbial enumeration 2021— The total bacterial count does not exceed 104 per g, and the total combined molds and yeasts count does not exceed 103 per g.
Content of triterpene glycosides—
Solution A, Solution B, Mobile phase, System suitability solution, Standard solution, 23-epi-26-Deoxyactein standard solutions, and Chromatographic system— Proceed as directed in the test for Content of triterpene glycosides under Black Cohosh.
Test solution— Use the Fluidextract, diluting if necessary with a suitable solvent to obtain a solution containing about 0.75 mg per mL of triterpene glycosides. Centrifuge, or pass through a filter having a 0.45-µm or finer porosity.
Procedure— Proceed as directed in the test for Content of triterpene glycosides under Black Cohosh. Calculate the content of triterpene glycosides, in percentage, in the portion of Fluidextract taken by adding the percentages calculated for the individual analytes.
Other requirements— It meets the requirements for Residual Solvents and Pesticide Residues under Botanical Extracts 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 988
Pharmacopeial Forum: Volume No. 33(5) Page 958