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       Belladonna Tincture contains, in 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
Ethanol (70 Per Cent)               a sufficient quantity

       Prepare about 900 mL of a tincture by percolation (Appendix 7.18). Determine the proportion of alkaloids in this tincture by the Assay and add, if necessary, sufficient Ethanol (70 Per Cent) to produce a Tincture containing, in each 100 mL, 30 mg of the alkaloids of belladonna leaf.

Strength available 0.3 mg per mL.

Dose Adults: 0.6 to 1 mL three or four times a day.
         Children: 0.03 mL per kg of body weight in three or four divided doses.

Other relevant information
       1. It may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, patients should observe caution while driving or performing other tasks requiring alertness.
       2. Transient stinging, dryness of mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headaches, allergic reactions, and somnolence may appear during uses.

Ethanol content 65.0 to 70.0 per cent v/v (Method II, Appendix 6.5).

Assay Carry out the determination as described in the “Gas Chromatography” (Appendix 3.4).
       pH 9.5 phosphate buffer, Diluent, Internal standard preparation, Standard preparation, Extraction blank, Standard curve, Chromatographic system, and System suitability Proceed as directed in the Assay under Belladonna Leaf.
       Assay preparation Proceed as directed in the Assay under Belladonna Leaf, but pipette 2 mL of Belladonna Tincture (in place of “10 mL of this solution”) into a 60-mL separator containing 10 mL of Diluent.
       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 sample. Add the quantity, in mg, of atropine and scopolamine, and multiply by 50 to obtain the weight, in mg, of alkaloids per 100 mL.

Other requirements Complies with the requirements described under “Tinctures” (Appendix 1.16).