Hyoscyamine Hydrobromide
(hye'' oh sye' a meen hye'' droe broe' mide).
C17H23NO3·HBr
370.28
370.28Benzeneacetic acid,
-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, hydrobromide [3(S)-endo]-.
1
h,5h-Tropan-3-ol (
)-tropate (ester) hydrobromide
[306-03-6].» Hyoscyamine Hydrobromide contains not less than 98.5 percent and not more than 100.5 percent of C17H23NO3·HBr, calculated on the dried basis. [Caution—Handle Hyoscyamine Hydrobromide with exceptional care, since it is highly potent.
]
Packaging and storage—
Preserve in tight, light-resistant containers.
USP Reference standards 
11
—
11—
USP Hyoscyamine Sulfate RS 
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Identification—
A:
Transfer 30 mg of Hyoscyamine Hydrobromide and 36 mg of USP Hyoscyamine Sulfate RS to individual 60-mL separators with the aid of 5-mL portions of water. To each separator add 1.5 mL of 1 N sodium hydroxide and 10 mL of chloroform. Shake for 1 minute, allow the layers to separate, and filter the chloroform extracts through separate filters of about 2 g of anhydrous granular sodium sulfate supported on pledgets of glass wool. Extract each aqueous layer with two additional 10-mL portions of chloroform, filtering and combining with the respective main extracts. Evaporate the chloroform solutions under reduced pressure to dryness, and dissolve each residue in 10 mL of carbon disulfide: the IR absorption spectrum, determined in a 1-mm cell, of the solution obtained from the test specimen exhibits maxima only at the same wavelengths as that of the solution obtained from the Reference Standard.
B:
To about 1 mL of a solution (1 in 20) add gold chloride TS, dropwise with shaking, until a definite precipitate separates. Add a small amount of 3 N hydrochloric acid, dissolve the precipitate with the aid of heat, and allow the solution to cool: lustrous reddish brown scales that may be accompanied by reddish brown needles are formed (distinction from atropine and scopolamine).
C:
To an aqueous solution (1 in 20) add silver nitrate TS: a yellowish-white precipitate is formed, and it is insoluble in nitric acid.
Melting temperature 741:
not less than 149
.
741:
not less than 149.
Loss on drying 731—
Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.
731—
Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281:
not more than 0.2%.
281:
not more than 0.2%.
Other alkaloids—
Dissolve 250 mg in 1 mL of 0.1 N hydrochloric acid, and dilute with water to 15 mL. To 5 mL of the solution add a few drops of platinic chloride TS: no precipitate is formed immediately. To another 5-mL portion add 2 mL of 6 N ammonium hydroxide: the mixture may develop a slight opalescence, but no turbidity or precipitate is formed immediately.
Assay—
Dissolve about 700 mg of Hyoscyamine Hydrobromide, 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 C17H23NO3·HBr.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Elena Gonikberg, Ph.D.
Principal Scientific Liaison 1-301-816-8251 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3464