Digitalis Capsules
»Digitalis Capsules contain an amount of Powdered Digitalis equivalent to not less than 85.0percent and not more than 120.0percent of the labeled potency.
Packaging and storage— Preserve in tight containers.
Microbial limits á61ñ It meets the requirements of the test for absence of Salmonellaspecies.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Standard preparation— Prepare as directed in the Assayunder Digitalis.
Assay preparation— Empty the contents of not less than 20Capsules into a hard-glass,glass-stoppered container of not less than 50-mLcapacity.Add a menstruum consisting of 4volumes of alcohol and 1volume of water so that the total volume of menstruum corresponds to 1mLfor each expected USP Digitalis Unit.Insert the stopper,the upper third of which is greased lightly with petrolatum.Shake the mixture at 25±5for 24±2hours by mechanical means,which continuously brings the solid material into fresh contact with the liquid phase.Immediately thereafter transfer to a centrifuge tube,centrifuge,and decant the supernatant tincture into a dry,hard-glass bottle having a tight closure.Preserve under refrigeration,and use within 30days.
Pigeons,Preparation of test dilutions,Injection of test dilutions,and Calculation of potency Proceed as directed in the Assayunder Digitalis.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 642
Phone Number:1-301-816-8343