U.S. PHARMACOPEIA

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Digitalis Tablets
» Digitalis Tablets contain an amount of Powdered Digitalis equivalent to not less than 85.0 percent and not more than 120.0 percent of the labeled potency.
Packaging and storage— Preserve in tight containers.
Microbial limits 61— It meets the requirements of the test for absence of Salmonella species.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
Standard preparation— Prepare as directed in the Assay under Digitalis.
Assay preparation— Weigh and finely powder not fewer than 25 Tablets. Weigh accurately a portion of the powder, equivalent to not less than 20 Tablets. Transfer to a dry, hard-glass, glass-stoppered container of not less than 50-mL capacity. Proceed as directed for the Assay preparation in the Assay under Digitalis Capsules, beginning with “Add a menstruum.”
Pigeons, Preparation of test dilutions, Injection of test dilutions, and Calculation of potency— Proceed as directed in the Assay under Digitalis.
Auxiliary Information— Staff Liaison : Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 700
Phone Number : 1-301-816-8318