» 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 enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the test for absence of Salmonella species.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements.
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.
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USP32NF27 Page 2145