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 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—
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Maged H. Sharaf, Ph.D.
Senior Scientist
1-301-816-8318		 (DSB05) Dietary Supplements - Botanicals
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106		 (BPC05) Biopharmaceutics05
USP32–NF27 Page 2145