Digitalis Capsules
» Digitalis Capsules 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.
USP Reference standards 11
USP Digitalis RS Click to View Structure
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the test for absence of Salmonella species.
Uniformity of dosage units 905: meet the requirements.
Assay—
Standard preparation— Prepare as directed in the Assay under Digitalis.
Assay preparation— Empty the contents of not less than 20 Capsules into a hard-glass, glass-stoppered container of not less than 50-mL capacity. Add a menstruum consisting of 4 volumes of alcohol and 1 volume of water so that the total volume of menstruum corresponds to 1 mL for each expected USP Digitalis Unit. Insert the stopper, the upper third of which is greased lightly with petrolatum. Shake the mixture at 25 ± 5 for 24 ± 2 hours 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 30 days.
Pigeons, Preparation of test dilutions, Injection of test dilutions, and Calculation of potency Proceed as directed in the Assay under Digitalis.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Maged H. Sharaf, Ph.D.
Principal Scientific Liaison
1-301-816-8318
(DS2010) Monographs - Dietary Supplements
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
62 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 2902