]non-[7-yl ester, hydrobromide, trihydrate, [7(S
)-tropate (ester) hydrobromide trihydrate
Packaging and storage
Preserve in tight, light-resistant containers.
Change to read:
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:
an amount equivalent to 50 mg of anhydrous Scopolamine Hydrobromide per mL, in water.
between 4.0 and 5.5, in a solution (1 in 20).
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.
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 C17
: Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29NF24 Page 1949
: Volume No. 31(1) Page 73
Phone Number : 1-301-816-8320