U.S. PHARMACOPEIA

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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 90.0 percent and not more than 110.0 percent of the labeled amount of C16H24N2O·HCl. It contains a suitable preservative.
Packaging and storage— Preserve in tight containers.
Identification— A volume of Ophthalmic Solution, equivalent to about 2.5 mg of oxymetazoline hydrochloride, responds to the Identification test under Oxymetazoline Hydrochloride Nasal Solution.
Sterility 71: meets the requirements.
pH 791: between 5.8 and 6.8.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase— Prepare as directed in the Assay under Oxymetazoline Hydrochloride.
Standard preparation— Prepare a solution of USP Oxymetazoline Hydrochloride RS in 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 Assay under Oxymetazoline Hydrochloride, except to calculate the quantity, in mg, of C16H24N2O·HCl in each mL of the Ophthalmic Solution taken by the formula:
C(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 1612
Phone Number : 1-301-816-8320