Black Cohosh Tablets
» Black Cohosh Tablets contain Powdered Black Cohosh Extract or Black Cohosh Fluidextract. Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of Powdered Extract or Fluidextract, represented by the content of triterpene glycosides, calculated as 23-epi-26-deoxyactein (C37H56O10).
Packaging and storage Preserve in tight, light-resistant containers, and store at room temperature.
Labeling The label states the Latin binomial and, following the official name, the article from which the Tablets were prepared. The label also indicates the amount, in mg per Tablet, of Powdered Extract or Fluidextract; the solvents used to prepare the Powdered Extract or Fluidextract; and the ratio of starting crude plant material to Powdered Extract or Fluidextract. Label it to indicate the content, in percentage, of triterpene glycosides as 23-epi-26-deoxyactein in the Powdered Extract or Fluidextract used to prepare the Tablets. The label bears 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.
USP Reference standards 11
USP Actein RS .
USP 23-epi-26-Deoxyactein RS.
USP Powdered Black Cohosh Extract RS.
A: Thin-Layer Chromatographic Identification Test 201
Test solution Take 10 mL of the Test solution prepared for Identification test B, evaporate to dryness, and redissolve in 1 mL of methanol.
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 Transfer a portion of powdered Tablets, equivalent to the labeled amount of Powdered Extract or Fluidextract containing about 25 mg of triterpene glycosides, to a suitable flask, add 25 mL of water, shake to disperse, and sonicate for 10 minutes. Add 75 mL of methanol, and sonicate for 10 minutes. Allow to stand for 15 minutes, and use the clear supernatant.
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, cimigenolarabinoside, and cimigenolxyloside 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 cimigenolarabinoside to cimigenolxyloside is not less than 0.4 (distinction from Cimicifuga foetida).
Weight variation 2091: meet the requirements.
Disintegration 2040: meet the requirements under Botanical Dosage Forms.
Microbial enumeration 2021 Tablets meet the requirements of the tests for absence of Salmonella species and Escherichia coli. The total bacterial count does not exceed 104 cfu per g, and the total combined molds and yeasts count does not exceed 103 cfu 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 Accurately weigh not fewer than 20 Tablets, and finely powder with a mortar and pestle. Transfer an accurately weighed quantity of the powder, equivalent to about 8 mg of triterpene glycosides, to a suitable polytef-capped centrifuge tube. Add 3 mL of water, shake to disperse, and sonicate for 10 minutes at 60. Add 3 mL of methanol, and sonicate for 10 minutes. Centrifuge, and transfer the clear supernatant to a 10-mL volumetric flask. Wash the residue twice with 1.5 mL of a mixture of methanol and water (1:1), and transfer the washings to the volumetric flask. Dilute with a mixture of methanol and water (1:1) to volume, mix, and pass through a membrane filter having a 0.45-µm or finer porosity.
Procedure Proceed as directed in the test for Content of triterpene glycosides under Black Cohosh. From the chromatogram obtained, determine the concentration, C, in µg per mL, of each triterpene glycoside. Calculate the quantity, in mg, of triterpene glycosides in the portion of Tablets taken by the formula:
CT /100in which CT is the sum of the concentrations C, in µg per mL, of all the relevant triterpene glycosides, calculated as 23-epi-26-deoxyactein.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 989Pharmacopeial Forum: Volume No. 33(5) Page 961
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.