Scopolamine Hydrobromide Trihydrate CAS 6533-68-2 Assay 98.5%-102.0%

Scopolamine Hydrobromide
C17H21NO4·HBr·3H2O 438.31
hydrobromide trihydrate [6533-68-2]
Anhydrous 384.27 [114-49-8].
» Scopolamine Hydrobromide contains not less than 98.5 percent and not more than 102.0 percent of C17H21NO4·HBr, calculated on the anhydrous basis.
Caution-Handle Scopolamine Hydrobromide with exceptional care, since it is highly potent.
Packaging and storage-Preserve in tight, light-resistant containers.
USP Reference standards <11>-
USP Scopolamine Hydrobromide RS
Identification-
A: Infrared Absorption <197K>-
Test specimen-Dissolve 3 mg in 1 mL of alcohol, and evaporate the solution on a steam bath to dryness. Dissolve the residue in 0.5 mL of chloroform, add 200 mg of potassium bromide, previously dried at 105° for 30 minutes, and stir frequently for 5 minutes. Allow the chloroform to evaporate to dryness, and stir frequently to obtain a flowing powder residue. Dry the residue on a steam bath for 5 minutes, then immediately compress the residue to a disk.
B: To 1 mL of a solution (1 in 20) add a few drops of chlorine TS, and shake the mixture with 1 mL of chloroform: the latter assumes a brownish color.
Specific rotation <781S>: between -24° and -26°.
Test solution: an amount equivalent to 50 mg of anhydrous Scopolamine Hydrobromide per mL, in water
pH <791>: between 4.0 and 5.5, in a solution (1 in 20).
Water, Method III <921>-Dry it in two stages (see Loss on drying <731>); first at 80° for 2 hours, and then at 105° for an additional 3 hours: it loses not more than 13.0% of its weight.
Residue on ignition <281>: negligible, from 100 mg.
Limit of apoatropine-To 15 mL of a solution (1 in 100) add 0.05 mL of 0.1 N potassium permanganate VS: the solution is not completely decolorized within 5 minutes.
Other foreign alkaloids-To 1 mL of a solution (1 in 20) add a few drops of 6 N ammonium hydroxide: no turbidity is produced. Add 1 N potassium hydroxide to another 1-mL portion of the solution: only a transient whitish turbidity is produced.
Assay-Dissolve about 750 mg of Scopolamine Hydrobromide, accurately weighed, in a mixture of 30 mL of glacial acetic acid and 10 mL of mercuric acetate TS, warming slightly to effect solution. Cool the solution to room temperature, add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 38.43mg of C17H21NO4·HBr.