Homatropine Methylbromide
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C17H24BrNO3 370.28

8-Azoniabicyclo[3.2.1]octane, 3-(hydroxyphenylacetyl)oxy-8,8-dimethyl-, bromide, endo-.

3-Hydroxy-8-methyl-1h,5h-tropanium bromide mandelate [80-49-9].
» Homatropine Methylbromide contains not less than 98.5 percent and not more than 100.5 percent of C17H24BrNO3, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
A: Infrared Absorption 197K. [note—If differences are observed, dissolve the specimen and the Reference Standard separately in methanol, and recrystallize by adding dioxane to each solution.]
B: Ultraviolet Absorption 197U
Solution: 1 mg per mL.
Medium: alcohol.
Absorptivities at 258 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: Mercuric-potassium iodide TS produces in a solution (1 in 50) a white or slightly yellowish precipitate, but no precipitation is caused by solutions of alkali hydroxides or carbonates, even in concentrated solutions of the substance (distinction from most alkaloids).
D: To a solution (1 in 50), add ammonium reineckate TS: a red precipitate is formed.
E: A solution (1 in 20) responds to the tests for Bromide 191.
pH 791: between 4.5 and 6.5, in a solution (1 in 100).
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.2%.
Homatropine, atropine, and other solanaceous alkaloids— To 1 mL of a solution of it (1 in 50), add a few drops of 6 N ammonium hydroxide, shake the solution with 5 mL of chloroform, and evaporate the separated chloroform layer on a steam bath to dryness. Warm the residue with 1.5 mL of a solution made by dissolving 500 mg of mercuric chloride in 25 mL of a mixture of 5 volumes of alcohol and 3 volumes of water: no yellow or red color develops.
Assay— Dissolve about 700 mg of Homatropine Methylbromide, accurately weighed, in a mixture of 50 mL of glacial acetic acid and 10 mL of mercuric acetate TS. Add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 37.03 mg of C17H24BrNO3.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
1-301-816-8251
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 2560
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.