Packaging and storage— Preserve in tight,light-resistant containers.

USP Reference standards á11ñ— USP Scopolamine Hydrobromide RS.

Identification— Place an amount of powdered Tablets,equivalent to about 3mg of scopolamine hydrobromide,in a 50-mLseparator,add 10mLof water,and shake for 2minutes.Proceed as directed in Identificationtest Aunder Scopolamine Hydrobromide Injection,beginning with “add 0.2mLof ammonium hydroxide.”

Disintegration á701ñ: 15minutes,the use of disks being omitted.

Uniformity of dosage units á905ñ: meet the requirements.

Assay— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 1.0mg of scopolamine hydrobromide,to a separator containing 5mLof pH9.0buffer,and add,by pipet,2.0mLof Internal standard solution(prepared as directed in the Assayunder Scopolamine Hydrobromide Injection).Adjust with 1Nsodium hydroxide to a pHof 9.0,extract with two 10-mLportions of methylene chloride,filter the methylene chloride extracts through 1g of anhydrous sodium sulfate supported by a small cotton plug in a funnel into a 50-mLbeaker,and evaporate under nitrogen to approximately 2.0mL.Using this as the Assay preparation,proceed as directed in the Assayunder Scopolamine Hydrobromide Injection.Calculate the quantity,in mg,of C17H21NO4·HBr·3H2Oin the portion of Tablets taken by the formula: in which Wis the weight,in mg,of USP Scopolamine Hydrobromide RSin the Standard solution;and 1.141is the ratio of the molecular weight of scopolamine hydrobromide trihydrate to that of anhydrous scopolamine hydrobromide and AUand ASare as defined therein.

Expert Committee:(PA6)Pharmaceutical Analysis 6

USP28–NF23Page 1757

Phone Number:1-301-816-8389