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Category  Antispasmodic.

             Stramonium Tincture contains not less than 0.0225 per cent w/v and not more than 0.0275 per cent w/v of the alkaloids of Stramonium, calculated as hyoscyamine.

Stramonium Tincture may be prepared as follows.

Stramonium, in moderately coarse powder       100 g
Ethanol (45 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 (45 Per Cent) to produce a Stramonium Tincture of the required strength.

Dose  Up to 6 mL daily, in divided doses.

Ethanol content  40.0 to 45.0 per cent v/v (Appendix 6.5).

Assay  Evaporate 100.0 mL on a water-bath to about 10 mL, and transfer to a separator with the aid of 25 mL of chloroform and a mixture of 10 mL of water and 3 mL of 5 M ammonia.  Shake well, allow to separate, and filter the chloroform layer into a second separator through a plug of absorbent cotton previously moistened with chloroform.  Continue the extraction with further 25-mL portions of chloroform until complete extraction of the alkaloids is effected (Appendix 7.4), running each chloroform solution through the same plug of cotton.  Extract the combined chloroform solutions with successive portions of a mixture of 3 volumes of 0.1 M sulfuric acid and 1 volume of ethanol until complete extraction of the alkaloids is effected, filtering each extract through a plug of cotton previously moistened with water.  Wash the mixed acid solutions with 10, 5, and 5 mL of chloroform, extracting each chloroform solution with the same 20 mL of 0.05 M sulfuric acid and rejecting the chloroform.  Combine the acid solutions, neutralize with 5 M ammonia, add 5 mL in excess, and shake with successive 25-mL portions of chloroform until complete extraction of the alkaloids is effected, washing each chloroform solution with the same 10 mL of water and filtering into a flask through a plug of absorbent cotton previously moistened with chloroform.  Distil most of the chloroform from the combined extracts and transfer the remainder of the solution to a shallow open dish.  Evaporate the reminder of the chloroform without the aid a current of air, heat the residue in an oven at 100° for 15 minutes, and dissolve in a little chloroform.  Evaporate to dryness without the aid of a current of air, and again heat in an oven at 100° for 15 minutes.  Dissolve the residue in 2 mL of chloroform, add 5.0 mL of 0.025 M sulfuric acid VS, warm to remove the chloroform, cool, and titrate the excess of acid with 0.05 M sodium hydroxide VS, using methyl red TS as indicator.  Perform a blank determination (Residual Titrations, Appendix 6.17).  Each mL of 0.025 M sulfuric acid VS is equivalent to 14.47 mg of alkaloids, calculated as hyoscyamine.

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