Cascara Tablets
»Cascara Tablets are prepared from Cascara Sagrada Extract.They contain an amount of hydroxyanthracene derivatives,calculated as cascaroside A,not less than 9.35percent and not more than 12.65percent of the labeled amount of Cascara Sagrada Extract.Not less than 50percent of the hydroxyanthracene derivatives are cascarosides,calculated as cascaroside A.
Packaging and storage— Preserve in tight containers;if the Tablets are coated,well-closed containers may be used.
Uniformity of dosage units á905ñ: meet the requirements.
Assay for cascarosides— [NOTE1—Perform all extractions by shaking vigorously,and allow all phases to separate completely before transferring.Entrainment of aglycones into the aqueous phase,as indicated by a value of less than 2.7for the ratio of the absorbance of the final solution at 515nm to that at 440nm,may lead to false results.NOTE2—Throughout this assay,use 1Nsodium hydroxide that is prepared without added barium ions as directed for Volumetric Solutionsunder Reagents,Indicators,and Solutions.]
Ferric chloride solution— Dissolve 100g of ferric chloride in water to make 100mL.
Assay solution— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 1.0g of Cascara Sagrada Extract,to a 100-mLvolumetric flask.Add about 60mLof 70%alcohol,swirl and/or sonicate for 15to 20minutes,several times,allow to stand overnight,sonicate or swirl for 10to 15minutes,dilute with 70%alcohol to volume,mix,and filter through suitable filter paper.
Assay preparation— Prepare as directed in the Assay for cascarosidesunder Cascara Sagrada.
Procedure— Pipet 20mLof Assay preparationinto a flask containing 2mLof Ferric chloride solutionand 12mLof hydrochloric acid.Proceed as directed for Procedurein the Assay for cascarosidesunder Cascara Sagrada,beginning with “Attach a condenser arranged for refluxing,and heat for 3hours,”except to evaporate a 15.0-mLportion of the methylene chloride solution instead of 20.0mL.Calculate the quantity,in mg,of cascarosides in the portion of Tablets taken by the formula:
103.5AU,
in which AUis the absorbance of the solution from the Assay preparation.
Assay for total hydroxyanthracene derivatives— [NOTE1—Perform all extractions by shaking vigorously,and allow all phases to separate completely before transferring.Entrainment of aglycones into the aqueous phase,as indicated by a value of less than 2.6for the ratio of the absorbance of the final solution at 515nm to that at 440nm,may lead to false results.NOTE2—Throughout this assay,use 1Nsodium hydroxide that is prepared without added barium ions as directed for Volumetric Solutionsin the section Reagents,Indicators,and Solutions.]
Ferric chloride solution and Assay solution—Prepare as directed in the Assay for cascarosides.
Assay preparation— Prepare as directed for Assay preparationin the Assay for total hydroxyanthracene derivativesunder Cascara Sagrada.
Procedure— Pipet 10mLof Assay preparationinto a flask containing 2mLof Ferric chloride solutionand 12mLof hydrochloric acid.Proceed as directed for Procedurein the Assay for cascarosidesunder Cascara Sagrada,beginning with “Attach a condenser arranged for refluxing,and heat for 3hours,”except to evaporate a 15.0-mLportion of the methylene chloride solution instead of 20.0mL.Calculate the quantity,in mg,of total hydroxyanthracene derivatives in the portion of Tablets taken by the formula:
206.9AU,
in which AUis the absorbance of the solution from the Assay preparation.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 367
Phone Number:1-301-816-8343