Powdered Digitalis
»Powdered Digitalis is Digitalis dried at a temperature not exceeding 60
![]() The potency of Powdered Digitalis is such that,when assayed as directed,100mg is equivalent to 1USP Digitalis Unit.*
NOTEWhen Digitalis is prescribed,Powdered Digitalis is to be dispensed.
Packaging and storage
Preserve in tight,light-resistant containers.Apackage of a suitable desiccant may be enclosed in the container.
Identification
A:
It conforms to the description for Ground Digitalisin the section Botanic characteristicsunder Digitalis.
B:
Transfer 100mg to a 15-mLcentrifuge tube containing 2.0mLof diluted alcohol and 1.0mLof lead acetate TS,mix,shake,and boil for 2minutes.Centrifuge,decant the supernatant into a second 15-mLcentrifuge tube,add 2.0mLof chloroform,and mix.Centrifuge,then remove the lower layer,and filter it through a chloroform-washed small column of anhydrous sodium sulfate (100to 300mg)into a 5-mLcentrifuge tube.Evaporate the chloroform solution under a stream of nitrogen to dryness,and dissolve the residue in 100µLof a mixture of methanol and chloroform (1:1).Prepare a Standard solution in the same manner,using 100mg of USP Digitalis RS(Standard solution A).Prepare a second Standard solution by dissolving USP Digitoxin RSand USP Gitoxin RSin a mixture of methanol and chloroform (1:1)such that the final concentration of each is approximately 0.2mg per mL(Standard solution B).Apply 10µLof the test solution,10µLof Standard solution A,and 10µLof Standard solution B,each as a narrow band about 15mm long,to a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture,and allow the bands to dry.Develop the chromatogram in a saturated chamber,using a solvent system consisting of a mixture of ethyl acetate,methanol,and water (30:4:3)until the solvent front has moved about 15cm from the origin.Mix 10mLof chloramine Tsolution (3in 100)with 40mLof a 1in 4solution of trichloroacetic acid in alcohol (store the mixture in a cool place,and use it within 1week),and spray the air-dried chromatographic plate with this mixture.Heat the plate at 110
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Microbial limits á61ñ
It meets the requirements of the test for absence of Salmonellaspecies.
Water,Method III,Procedure for Articles of Botanical Origin á921ñ:
not more than 5.0%.
Acid-insoluble ash á561ñ:
not more than 5.0%.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
*
One USP Digitalis Unit represents the potency of 100mg of USP Digitalis RS.
Auxiliary Information
Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28NF23Page 641
Phone Number:1-301-816-8343
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