Belladonna Extract Tablets
»Belladonna Extract Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of the alkaloids of belladonna leaf.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Macerate a quantity of powdered Tablets,equivalent to about 5mg of the alkaloids of belladonna extract,with 20mLof water,and transfer to a separator.Render the solution alkaline with 6Nammonium hydroxide,and extract the alkaloids with 50mLof chloroform.Filter the chloroform layer,divide it into two equal portions,and evaporate to dryness:the residue responds to the following tests.
A: To one portion of the dry residue add 2drops of nitric acid,evaporate on a steam bath to dryness,and add a few drops of alcoholic potassium hydroxide TS:a violet color is produced.
B: Dissolve the other portion of the residue in 1mLof dilute hydrochloric acid (1in 120),and add gold chloride TS,dropwise with shaking,until a definite precipitate separates.Slowly heat until the precipitate dissolves,and allow the solution to cool:a lusterless precipitate is produced.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
pH9.5phosphate buffer, Internal standard solution,Standard preparation,Extraction blank,Standard curve,Chromatographic system,and System suitability—Proceed as directed in the Assayunder Belladonna Extract.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 600µg of atropine and scopolamine,to a 60-mLseparator,add 10.0mLof dilute sulfuric acid (1in 350),and sonicate to dissolve as much as possible of the specimen.Proceed as directed for Assay preparationin the Assayunder Belladonna Leaf,beginning with “add 1.0mLof Internal standard solution.”
Procedure— Proceed as directed for Procedurein the Assayunder Belladonna Extract.Record from the Standard curvesthe quantities,in mg,of atropine and scopolamine in the weight of specimen taken.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 224
Phone Number:1-301-816-8343