Oxymetazoline Hydrochloride Ophthalmic Solution, chemical structure, molecular formula, Reference Standards

Oxymetazoline Hydrochloride Ophthalmic Solution

»Oxymetazoline Hydrochloride Ophthalmic Solution is a sterile,buffered solution of Oxymetazoline Hydrochloride in water adjusted to a suitable tonicity.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C16H24N2O·HCl.It contains a suitable preservative.

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Oxymetazoline Hydrochloride RS.

Identification— Avolume of Ophthalmic Solution,equivalent to about 2.5mg of oxymetazoline hydrochloride,responds to the Identificationtest under Oxymetazoline Hydrochloride Nasal Solution.

Sterility á71ñ: meets the requirements.

pHá791ñ: between 5.8and 6.8.

Assay—

Mobile phase— Prepare as directed in the Assayunder Oxymetazoline Hydrochloride.

Standard preparation— Prepare a solution of USP Oxymetazoline Hydrochloride RSin Mobile phase,having a known concentration approximately equal to the labeled concentration of the Ophthalmic Solution.

Assay preparation— Use Ophthalmic Solution.

Chromatographic system and Procedure—Proceed as directed in the Assayunder Oxymetazoline Hydrochloride,except to calculate the quantity,in mg,of C16H24N2O·HCl in each mLof the Ophthalmic Solution taken by the formula:

C(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 1445

Phone Number:1-301-816-8389