Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, chemical structure, molecular formula, Reference Standards

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 90.0percent and not more than 110.0percent 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 Iamber 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.

USP Reference standards á11ñ— USP Diacetylfluorescein RS.USP Proparacaine Hydrochloride RS.

Identification—

A: It responds to Identificationtest Aunder Fluorescein Sodium.

B: It responds to the Identificationtest under Proparacaine Hydrochloride Ophthalmic Solution.

Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.

pHá791ñ: between 4.0and 5.2.

Assay for fluorescein sodium—

Standard preparation— Prepare as directed in the Assayunder Fluorescein Sodium.

Assay preparation— Using Ophthalmic Solution,prepare as directed in the Assayunder Fluorescein Sodium.

Procedure— Proceed as directed for Procedurein the Assayunder 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 Assayunder Proparacaine Hydrochloride Ophthalmic Solution.

Assay preparation— Using Ophthalmic Solution,prepare as directed for Assay preparationunder Proparacaine Hydrochloride Ophthalmic Solution.

Procedure— Proceed as directed for Procedurein the Assayunder Proparacaine Hydrochloride Ophthalmic Solution.Calculate the quantity,in mg,of proparacaine hydrochloride (C16H26N2O3·HCl)in each mLof Ophthalmic Solution taken by the formula:

100(C/V)(rU/rS),

in which the terms are as defined therein.

Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist

Expert Committee:(PA6)Pharmaceutical Analysis 6

USP28–NF23Page 845

Phone Number:1-301-816-8389