USP Monographs: Scopolamine Hydrobromide

Scopolamine Hydrobromide

C17H21NO4·HBr·3H2O

438.31

Benzeneacetic acid,

-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3.31.0.2,4]non-[7-yl ester, hydrobromide, trihydrate, [7(S)-(1

)]-.

-Epoxy-1

H,5

H-tropan-3

-ol (

)-tropate (ester) 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

— USP Scopolamine Hydrobromide RS.

Change to read:

Identification—

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.

USP29

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

and

Test solution: an amount equivalent to 50 mg of anhydrous Scopolamine Hydrobromide per mL, in water.

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.

Organic volatile impurities, Method I

467

: meets the requirements.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

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 38.43 mg of C17H21NO4·HBr.

Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 1949

Pharmacopeial Forum : Volume No. 31(1) Page 73

Phone Number : 1-301-816-8320