» 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
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 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.
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USP35NF30 Page 2902