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USP 35 Official Monographs / Digitalis 2901 Assay— dence Intervals for Individual Assays in Design and Analysis of Bio- Standard preparation—Weigh the contents of 1 container of logical Assays 111). If L exceeds 0.30, repeat the assay or inject USP Digitalis RS to the nearest mg, either in the original con- more pigeons with one or both preparations until the confi- tainer or in a weighing bottle, and transfer to a dr y, hard-glass, dence interval is 0.30 or less. glass-stoppered container or centrifuge tube of at least 50-mL The potency of Digitalis, calculated from that of the Assay capacity. Complete the weighing within 5 minutes after open- preparation, is satisfactory if the result is not less than 0.85 USP ing the ampul. Add a menstruum consisting of 4 volumes of Digitalis Unit per 100 mg. alcohol and 1 volume of water so that the total volume of menstruum added corresponds to 10 mL for each g of powder. Insert the stopper, the upper third of which is greased lightly with petrolatum. Shake the mixture for 24  2 hours at 25  5 Powdered Digitalis by mechanical means, which continuously brings the solid ma- terial into fresh contact with the liquid phase. Immediately thereafter transfer, if necessar y, to a centrifuge tube, centrifuge, » Powdered Digitalis is Digitalis dried at a tem- and decant the supernatant tincture into a dr y, hard-glass bot- perature not exceeding 60 , reduced to a fine or tle having a tight closure. Preser ve under refrigeration, and use a very fine powder, and adjusted, if necessar y, to within 30 days.