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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
Scientist
1-301-816-8320		 (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2406
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.