Epinephrine Bitartrate for Ophthalmic Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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).

1 Packaging and storage

—Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution.

Completeness of solution 〈641〉—A 100-mg portion dissolves in 5 mL of water to yield a clear solution.

2 Constituted solution

—At the time of use, it meets the requirements for Injections and Implanted Drug Products 〈1〉, Specific Tests, Completeness and clarity of solutions.

3 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〉.