Scopolamine Hydrobromide Ophthalmic Solution
» Scopolamine Hydrobromide Ophthalmic Solution is a sterile, buffered, aqueous solution of Scopolamine Hydrobromide. It contains not less than 90.0 percent and not more than 110.0 percent 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.
A: A volume of Ophthalmic Solution, equivalent to about 3 mg of scopolamine hydrobromide, responds to Identification test A under Scopolamine Hydrobromide Injection.
B: Add to the Ophthalmic Solution silver nitrate TS: a yellowish white precipitate, insoluble in nitric acid but slightly soluble in 6 N ammonium hydroxide, is formed.
Sterility 71: meets the requirements.
pH 791: between 4.0 and 6.0.
Assay— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 10 mg of scopolamine hydrobromide, to a 100-mL volumetric flask, dilute with water to volume, and mix. Using this as the Assay solution, proceed as directed in the Assay under Scopolamine Hydrobromide Injection. Calculate the quantity, in mg, of C17H21NO4·HBr·3H2O in the volume of Ophthalmic Solution 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 3542