Scopolamine Hydrobromide Tablets
» Scopolamine Hydrobromide Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C17H21NO4·HBr·3H2O.
Packaging and storage Preserve in tight, light-resistant containers.
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.
Disintegration 701: 15 minutes, the use of disks being omitted.
Uniformity of dosage units 905: meet the requirements.
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 C17H21NO4·HBr·3H2O 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.
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USP32NF27 Page 3542