U.S. PHARMACOPEIA

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Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution
» Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution is a sterile aqueous solution of Fluorescein Sodium and Proparacaine Hydrochloride. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of fluorescein sodium (C20H10Na2O5) and proparacaine hydrochloride (C16H26N2O3·HCl). It contains a suitable preservative.
Packaging and storage— Preserve in tight, light-resistant containers, preferably of Type I amber glass, and store in a refrigerator.
Labeling— Label it to state that it is to be stored in a refrigerator before and after the container is opened.
Identification—
A: It responds to Identification test A under Fluorescein Sodium.
B: It responds to the Identification test under Proparacaine Hydrochloride Ophthalmic Solution.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 4.0 and 5.2.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for fluorescein sodium—
Standard preparation— Prepare as directed in the Assay under Fluorescein Sodium.
Assay preparation— Using Ophthalmic Solution, prepare as directed in the Assay under Fluorescein Sodium.
Procedure— Proceed as directed for Procedure in the Assay under Fluorescein Sodium. Calculate the quantity, in mg, of fluorescein sodium (C20H10Na2O5) in the volume of Ophthalmic Solution taken by the formula:
3333C(IU / IS),
in which the terms are as defined therein.
Assay for proparacaine hydrochloride—
Standard preparation— Prepare as directed for Standard preparation in the Assay under Proparacaine Hydrochloride Ophthalmic Solution.
Assay preparation— Using Ophthalmic Solution, prepare as directed for Assay preparation under Proparacaine Hydrochloride Ophthalmic Solution.
Procedure— Proceed as directed for Procedure in the Assay under Proparacaine Hydrochloride Ophthalmic Solution. Calculate the quantity, in mg, of proparacaine hydrochloride (C16H26N2O3·HCl) in each mL of Ophthalmic Solution taken by the formula:
100(C / V)(rU / rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 933
Phone Number : 1-301-816-8320