Belladonna Tincture
»Belladonna Tincture yields,from each 100mL,not less than 27mg and not more than 33mg of the alkaloids of belladonna leaf.
Belladonna Leaf,in moderately
coarse powder		 100g
To make about 1000mL
Prepare a tincture by Process Pas modified for assayed Tinctures(see Pharmaceutical Dosage Forms á1151ñ),using a mixture of 3volumes of alcohol and 1volume of water as the menstruum.Finally adjust the Tincture to contain,in each 100mL,30mg of the alkaloids of belladonna leaf.
Packaging and storage— Preserve in tight,light-resistant containers,and avoid exposure to direct sunlight and to excessive heat.
Alcohol content,Method IIá611ñ: between 65.0%and 70.0%of C2H5OH,determined by the gas-liquid chromatographic procedure,acetone being used as the internal standard.
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— Proceed with Tincture as directed in the Assayunder Belladonna Leaf,but pipet 2mLof Tincture (in place of “10mLof this solution”)into a 60-mLseparator containing 10mLof dilute sulfuric acid (1in 350).
Procedure— Proceed as directed in the Assayunder Belladonna Leaf.Record from the Standard curvethe quantities,in mg,of atropine and scopolamine in the specimen.Add the quantity,in mg,of atropine and scopolamine,and multiply by 50to obtain the weight,in mg,of alkaloids per 100mL.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 225
Phone Number:1-301-816-8343
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