Scopolamine Hydrobromide Ophthalmic Ointment
» Scopolamine Hydrobromide Ophthalmic Ointment is Scopolamine Hydrobromide in a suitable ophthalmic ointment base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of (C17H21NO4)·HBr·3H2O. It is sterile.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
A: Transfer a portion of Ophthalmic Ointment, equivalent to about 50 mg of scopolamine hydrobromide, to a suitable separator, and dissolve in 25 mL of ether. Add 25 mL of 0.01 N hydrochloric acid, shake vigorously, allow the layers to separate, and discard the organic phase. Proceed as directed under Identification—Organic Nitrogenous Bases 181, beginning with “In a second separator dissolve 50 mg.”
B: Transfer about 5 g of Ophthalmic Ointment to a separator, dissolve in 50 mL of ether, and extract with 20 mL of water: the extracted solution so obtained responds to the tests for Bromide 191.
Sterility 71: meets the requirements.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Assay— Proceed with Ophthalmic Ointment as directed in the Assay under Scopolamine Hydrobromide Injection, but to prepare the Assay solution, weigh accurately a portion of Ophthalmic Ointment equivalent to about 10 mg of scopolamine hydrobromide into a separator containing 50 mL of ether, shake to dissolve, extract with three 25-mL portions of 0.2 N sulfuric acid, collect the acid extracts in a 100-mL volumetric flask, dilute with 0.2 N sulfuric acid to volume, and mix. Calculate the quantity, in mg, of C17H21NO4·HBr·3H2O in the portion of Ophthalmic Ointment taken by the formula given therein.
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Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3541