Digitalis Tablets
»Digitalis Tablets 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— Weigh and finely powder not fewer than 25Tablets.Weigh accurately a portion of the powder,equivalent to not less than 20Tablets.Transfer to a dry,hard-glass,glass-stoppered container of not less than 50-mLcapacity.Proceed as directed for the Assay preparationin the Assayunder Digitalis Capsules,beginning with “Add a menstruum.”
Pigeons,Preparation of test dilutions,Injection of test dilutions,andCalculation 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