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       Belladonna Leaf Extract contains, in each 100 g, not less than 1.15 g and not more than 1.35 g of the alkaloids of belladonna leaf.
       Pilular Belladonna Leaf Extract
       Prepare the extract by percolating 1000 g of Belladonna Leaf, using a mixture of 3 volumes of Ethanol (95 Per Cent) and 1 volume of Purified Water as the menstruum. Macerate the drug for 16 hours, and then percolate it at a moderate rate. Evaporate the percolate under reduced pressure and at a temperature not exceeding 60 to a pilular consistency, and adjust the remaining extract, after assaying, by dilution with Liquid Glucose so that the finished Extract will contain, in each 100 g, 1.25 g of the alkaloids of belladonna leaf.
       Powdered Belladonna Leaf Extract
Prepare the extract by percolating 1000 g of Belladonna Leaf, using Ethanol (95 Per Cent) as the menstruum. Macerate the drug for 16 hours, and then percolate it slowly. Evaporate the percolate under reduced pressure and at a temperature not exceeding 60 to a soft extract, add 50 g of dry starches and continue the evaporation, at the same temperature, until the product is dry. Powder the residue. The extract may be deprived of its fat by treating either the soft extract first obtained, or the dry and powdered extract, as directed under “Extracts” (Appendix 1.16). Assay the powdered residue, and add sufficient Starches, previously dried at 100, to obtain a finished Extract containing 1.25 g of the alkaloids of belladonna leaf in each 100 g. Mix the powders, and pass the Extract through a fine sieve.

Packaging and storage Belladonna Leaf Extract shall be kept in tightly closed containers and stored at a temperature not exceeding 30°.

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 Weigh accurately about 500 mg of Belladonna leaf Extract, transfer to a 125-mL conical flask, and add 40 mL of Diluent. Heat to a temperature not above 45°, and stir to hasten solution. Filter the solution through a filter paper into a 100-mL volumetric flask. Wash the flask and the filter with two 20-mL portions of warmed Diluent, and collect the washings in the 100-mL volumetric flask. Add Diluent to volume, and mix.
       Pipette 10 mL of this solution into a 60-mL separator. To the separator add 1.0 mL of Internal standard solution, then add 15 mL of chloroform, shake vigorously, allow the layers to separate, and discard the chloroform layer. (If emulsions are formed, a mixed solvent consisting of 10 volumes of chloroform and 3 volumes of 2-propanol may be substituted for chloroform throughout the extraction procedure.) Add another 15 mL of chloroform, and extract again, discarding the chloroform phase. Add 15 mL of pH 9.5 Phosphate buffer and sufficient 1 M sodium hydroxide to yield a final pH between 9.0 and 9.5. Add 15 mL of chloroform, shake vigorously, and allow the layers to separate. Filter the organic phase through 10 g of anhydrous sodium sulfate, previously washed with chloroform and supported in a funnel with a small pledget of glass wool, into a suitable container. Extract again with two 15-mL portions of chloroform, again collecting the clarified organic phase. Wash the sodium sulfate and the tip of the funnel with 5 mL of chloroform. Evaporate the combined organic phases under reduced pressure, at a temperature below 45°, add 1 mL of chloroform, and mix to dissolve the alkaloids, taking care to wet the sides of the container.
       Procedure Proceed as directed for Procedure in the Assay under Belladonna Leaf. Record from the Standard curve the quantities, in mg, of atropine and scopolamine in the volume of sample taken. Add the quantity, in mg, of atropine and scopolamine, and multiply by 10 to obtain the weight, in mg, of alkaloids in the portion of the Extract taken.

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