U.S. PHARMACOPEIA

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Belladonna Tincture
» Belladonna Tincture yields, from each 100 mL, not less than 27 mg and not more than 33 mg of the alkaloids of belladonna leaf.
Belladonna Leaf, in moderately
coarse powder		 100 g
To make about 1000 mL
Prepare a tincture by Process P as modified for assayed Tinctures (see Pharmaceutical Dosage Forms 1151), using a mixture of 3 volumes of alcohol and 1 volume of water as the menstruum. Finally adjust the Tincture to contain, in each 100 mL, 30 mg 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 II 611: between 65.0% and 70.0% of C2H5OH, determined by the gas-liquid chromatographic procedure, acetone being used as the internal standard.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
pH 9.5 Phosphate buffer , Internal standard solution, Standard preparation, Extraction blank, Standard curve, Chromatographic system, and System suitability—Proceed as directed in the Assay under Belladonna Extract.
Assay preparation— Proceed with Tincture as directed in the Assay under Belladonna Leaf, but pipet 2 mL of Tincture (in place of “10 mL of this solution”) into a 60-mL separator containing 10 mL of dilute sulfuric acid (1 in 350).
Procedure— Proceed as directed in the Assay under Belladonna Leaf. Record from the Standard curve the quantities, in mg, of atropine and scopolamine in the specimen. Add the quantity, in mg, of atropine and scopolamine, and multiply by 50 to obtain the weight, in mg, of alkaloids per 100 mL.
Auxiliary Information— Staff Liaison : Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 245
Phone Number : 1-301-816-8318