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 90.0percent and not more than 110.0percent of the labeled amount of epinephrine (C9H13NO3).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Completeness of solution á641ñ— A100-mg portion dissolves in 5mLof water to yield a clear solution.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Other requirements— Asolution of it responds to the Identificationtest under Epinephrine Nasal Solution,and meets the requirements of the Assayunder Epinephrine Bitartrate Ophthalmic Solution.It meets also the requirements under Sterility Tests á71ñand Uniformity of Dosage Units á905ñ.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 743
Phone Number:1-301-816-8379