A: Triturate a quantity of Tablets,equivalent to about 5mg of atropine sulfate,with 10mLof water for a few minutes,and filter into a small separator.Render the solution alkaline with 6Nammonium hydroxide,and extract with 50mLof chloroform.Filter the chloroform layer,and evaporate to dryness.The residue so obtained meets the requirements under Identification—Organic Nitrogenous Bases á181ñ.

B: Afiltered solution of Tablets responds to the tests for Sulfate á191ñ.

pH9.0Buffer,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Atropine Sulfate Ophthalmic Solution.

Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 1mg of atropine sulfate,to a separator,and proceed as directed for the Assay preparationin the Assayunder Atropine Sulfate Ophthalmic Solution,beginning with “Add 2.0mLof Internal standard solution.”

Procedure— Proceed as directed in the Assayunder Atropine Sulfate Ophthalmic Solution.Calculate the quantity,in mg,of atropine sulfate [(C17H23NO3)2·H2SO4·H2O]in the portion of Tablets taken by the formula: in which 694.85and 676.83are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate,respectively;Wis the weight,in mg,of USP Atropine Sulfate RSin the Standard preparation;and RUand RSare as defined therein.