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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.
Microbial enumeration tests
Uniformity of dosage units
Assay
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
Auxiliary Information
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USP32NF27 Page 2145
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