Cascara Tablets
» Cascara Tablets are prepared from Cascara Sagrada Extract. They contain an amount of hydroxyanthracene derivatives, calculated as cascaroside A, not less than 9.35 percent and not more than 12.65 percent of the labeled amount of Cascara Sagrada Extract. Not less than 50 percent 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.
Disintegration 701: 60 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay for cascarosides— [Note 1—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 2.7 for the ratio of the absorbance of the final solution at 515 nm to that at 440 nm, may lead to false results. Note 2—Throughout this assay, use 1 N sodium hydroxide that is prepared without added barium ions as directed for Volumetric Solutions under Reagents, Indicators, and Solutions.]
Ferric chloride solution— Dissolve 100 g of ferric chloride in water to make 100 mL.
Assay solution— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 1.0 g of Cascara Sagrada Extract, to a 100-mL volumetric flask. Add about 60 mL of 70% alcohol, swirl and/or sonicate for 15 to 20 minutes, several times, allow to stand overnight, sonicate or swirl for 10 to 15 minutes, dilute with 70% alcohol to volume, mix, and filter through suitable filter paper.
Assay preparation— Prepare as directed in the Assay for cascarosides under Cascara Sagrada.
Procedure— Pipet 20 mL of Assay preparation into a flask containing 2 mL of Ferric chloride solution and 12 mL of hydrochloric acid. Proceed as directed for Procedure in the Assay for cascarosides under Cascara Sagrada, beginning with “Attach a condenser arranged for refluxing, and heat for 3 hours,” except to evaporate a 15.0-mL portion of the methylene chloride solution instead of 20.0 mL. Calculate the quantity, in mg, of cascarosides in the portion of Tablets taken by the formula:
103.5AU
in which AU is the absorbance of the solution from the Assay preparation.
Assay for total hydroxyanthracene derivatives— [Note 1—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 2.6 for the ratio of the absorbance of the final solution at 515 nm to that at 440 nm, may lead to false results. Note 2—Throughout this assay, use 1 N sodium hydroxide that is prepared without added barium ions as directed for Volumetric Solutions in 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 preparation in the Assay for total hydroxyanthracene derivatives under Cascara Sagrada.
Procedure— Pipet 10 mL of Assay preparation into a flask containing 2 mL of Ferric chloride solution and 12 mL of hydrochloric acid. Proceed as directed for Procedure in the Assay for cascarosides under Cascara Sagrada, beginning with “Attach a condenser arranged for refluxing, and heat for 3 hours,” except to evaporate a 15.0-mL portion of the methylene chloride solution instead of 20.0 mL. Calculate the quantity, in mg, of total hydroxyanthracene derivatives in the portion of Tablets taken by the formula:
206.9AU
in which AU is the absorbance of the solution from the Assay preparation.
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
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106		 (BPC05) Biopharmaceutics05
USP32–NF27 Page 1813