Scopolamine Hydrobromide Ophthalmic Solution, chemical structure, molecular formula, Reference Standards

Scopolamine Hydrobromide Ophthalmic Solution

»Scopolamine Hydrobromide Ophthalmic Solution is a sterile,buffered,aqueous solution of Scopolamine Hydrobromide.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C17H21NO4·HBr·3H2O.It may contain suitable antimicrobial agents and stabilizers,and may contain suitable additives for the purpose of increasing its viscosity.

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Scopolamine Hydrobromide RS.

Identification—

A: Avolume of Ophthalmic Solution,equivalent to about 3mg of scopolamine hydrobromide,responds to Identificationtest Aunder Scopolamine Hydrobromide Injection.

B: Add to the Ophthalmic Solution silver nitrate TS:a yellowish white precipitate,insoluble in nitric acid but slightly soluble in 6Nammonium hydroxide,is formed.

Sterility á71ñ: meets the requirements.

pHá791ñ: between 4.0and 6.0.

Assay— Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 10mg of scopolamine hydrobromide,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Using this as the Assay solution,proceed as directed in the Assayunder Scopolamine Hydrobromide Injection.Calculate the quantity,in mg,of C17H21NO4·HBr·3H2Oin the volume of Ophthalmic Solution taken by the formula given therein.

Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist

Expert Committee:(PA6)Pharmaceutical Analysis 6

USP28–NF23Page 1757

Phone Number:1-301-816-8389