Epinephrine Bitartrate for Ophthalmic Solution
» Epinephrine Bitartrate for Ophthalmic Solution is a sterile, dry mixture of Epinephrine Bitartrate and suitable antioxidants, prepared by freeze-drying. It contains an amount of epinephrine bitartrate equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of epinephrine (C9H13NO3).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Completeness of solution 641 A 100-mg portion dissolves in 5 mL of water to yield a clear solution.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Other requirements— A solution of it responds to the Identification test under Epinephrine Nasal Solution, and meets the requirements of the Assay under Epinephrine Bitartrate Ophthalmic Solution. It meets also the requirements under Sterility Tests 71 and Uniformity of Dosage Units 905.
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Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
USP35–NF30 Page 3057