Scopolamine Hydrobromide Ophthalmic Ointment
»Scopolamine Hydrobromide Ophthalmic Ointment is Scopolamine Hydrobromide in a suitable ophthalmic ointment base.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of (C17H21NO4)·HBr·3H2O.It is sterile.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Identification—
A: Transfer a portion of Ophthalmic Ointment,equivalent to about 50mg of scopolamine hydrobromide,to a suitable separator,and dissolve in 25mLof ether.Add 25mLof 0.01Nhydrochloric acid,shake vigorously,allow the layers to separate,and discard the organic phase.Proceed as directed under Identification—Organic Nitrogenous Bases á181ñ,beginning with “In a second separator dissolve 50mg.”
B: Transfer about 5g of Ophthalmic Ointment to a separator,dissolve in 50mLof ether,and extract with 20mLof water:the extracted solution so obtained responds to the tests for Bromide á191ñ.
Sterility á71ñ: meets the requirements.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments á751ñ.
Assay— Proceed with Ophthalmic Ointment as directed in the Assayunder Scopolamine Hydrobromide Injection,but to prepare the Assay solution,weigh accurately a portion of Ophthalmic Ointment equivalent to about 10mg of scopolamine hydrobromide into a separator containing 50mLof ether,shake to dissolve,extract with three 25-mLportions of 0.2Nsulfuric acid,collect the acid extracts in a 100-mLvolumetric flask,dilute with 0.2Nsulfuric acid to volume,and mix.Calculate the quantity,in mg,of C17H21NO4·HBr·3H2Oin the portion of Ophthalmic Ointment 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