Identification—
Place an amount of powdered Tablets, equivalent to about 3 mg of scopolamine hydrobromide, in a 50-mL separator, add 10 mL of water, and shake for 2 minutes. Proceed as directed in
Identification test
A under
Scopolamine Hydrobromide Injection, beginning with “add 0.2 mL of ammonium hydroxide.”
Assay—
Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 1.0 mg of scopolamine hydrobromide, to a separator containing 5 mL of
pH 9.0 buffer, and add, by pipet, 2.0 mL of
Internal standard solution (prepared as directed in the
Assay under
Scopolamine Hydrobromide Injection). Adjust with 1 N sodium hydroxide to a pH of 9.0, extract with two 10-mL portions of methylene chloride, filter the methylene chloride extracts through 1 g of anhydrous sodium sulfate supported by a small cotton plug in a funnel into a 50-mL beaker, and evaporate under nitrogen to approximately 2.0 mL. Using this as the
Assay preparation, proceed as directed in the
Assay under
Scopolamine Hydrobromide Injection. Calculate the quantity, in mg, of C
17H
21NO
4·HBr·3H
2O in the portion of Tablets taken by the formula:
1.141(W / 10)(AU / AS),
in which
W is the weight, in mg, of
USP Scopolamine Hydrobromide RS in the
Standard solution; and 1.141 is the ratio of the molecular weight of scopolamine hydrobromide trihydrate to that of anhydrous scopolamine hydrobromide and
AU and
AS are as defined therein.
701
:
15 minutes, the use of disks being omitted.